Part Part 1 - Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 - Class I medical devices | Zoe
Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
Part 1Class I medical devices
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This instrument is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.
3 Authority
This instrument is made under subsections 41FDB(7) and 41FDB(8) of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:
(a) conformity assessment certificate;
(b) conformity assessment document;
(c) conformity assessment procedures;
(d) included in the Register;
(e) kind, in relation to a medical device;
(f) medical device;
(g) system or procedure pack.
In this instrument:
Act means the Therapeutic Goods Act 1989.
application means an application to the Secretary for a kind of medical device to be included in the Register under section 41FC of the Act.
applied Directive 90/385 has the meaning given to “Directive 90/385” in regulation 2(1) of the UK Regulations, and a reference to an Annex in applied Directive 90/385 is to be construed in accordance with regulation 2(1A) of the UK Regulations.
applied Directive 93/42 has the meaning given to “Directive 93/42” in regulation 2(1) of the UK Regulations, and a reference to an Annex in applied Directive 93/42 is to be construed in accordance with regulation 2(1A) of the UK Regulations.
applied Directive 98/79 has the meaning given to “Directive 98/79” in regulation 2(1) of the UK Regulations, and a reference to an Annex in applied Directive 98/79 is to be construed in accordance with regulation 2(1A) of the UK Regulations.
Canadian medical devices regulations means the Medical Devices Regulations (SOR/98-282) made under the Food and Drugs Act of Canada, as in force immediately before the commencement of this instrument.
certified translation means a translation that contains a statement, dated and signed by a person, to the effect that the translation is a true and complete translation of the accompanying document.
Class 1 IVD medical device has the same meaning as in the Regulations.
Class 2 IVD medical device has the same meaning as in the Regulations.
Class 3 IVD medical device has the same meaning as in the Regulations.
Class 4 IVD medical device has the same meaning as in the Regulations.
Class 4 in-house IVD medical device has the same meaning as in the Regulations.
Class I medical device has the same meaning as in the Regulations.
Class IIa medical device has the same meaning as in the Regulations.
Class IIb medical device has the same meaning as in the Regulations.
Class III medical device has the same meaning as in the Regulations.
clinical evaluation report means a report prepared by a manufacturer detailing the assessment and analysis of clinical data to verify the safety and performance of a medical device when used as intended by the manufacturer.
Council Directive 90/385/EEC means Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) of the Council of the European Communities, as in force immediately before the commencement of this instrument.
Council Directive 93/42/EEC means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices of the Council of the European Communities, as in force immediately before the commencement of this instrument.
Directive 98/79/EC means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, as in force immediately before the commencement of this instrument.
EU IVD regulation means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force on 1 December 2024.
EU medical devices regulation means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force immediately before the commencement of this instrument.
generic device group has the same meaning as in the EU IVD regulation.
IAF accredited conformity assessment body means a body that is accredited to undertake certification for compliance with ISO 13485 by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA.
implantable medical device has the same meaning as in the Regulations.
in-house IVD medical device has the same meaning as in the Regulations.
instructions for use has the same meaning as in the Regulations.
ISO 13485 means International Standard ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, issued by the International Organization for Standardization in March 2016, as in force or existing immediately before the commencement of this instrument.
IVD companion diagnostic has the same meaning as in the Regulations.
IVD medical device, or in vitro diagnostic medical device, has the same meaning as in the Regulations.
IVD medical device for self-testing has the same meaning as in the Regulations.
Japanese PMD Act means The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices of Japan, as in force immediately before the commencement of this instrument.
manufacturing licence has the same meaning as in the Regulations.
MDSAP certificate means a certification document issued by a recognised or authorised auditing organisation, following the completion of an audit of a manufacturer’s quality management system.
measuring function has the same meaning as in the Regulations.
medical device used for a special purpose has the same meaning as in the Regulations.
NATA has the same meaning as in the Regulations.
notified body means a body that has been designated by a member state of the European Union, and notified to the European Commission, to assess the conformity of medical devices, including in vitro diagnostic medical devices and active implantable medical devices.
point of care testing has the same meaning as in the Regulations.
quality management system certificate means a certificate that is issued following an assessment of a manufacturer’s quality management system, but does not include a MDSAP certificate.
recognised or authorised auditing organisation means an organisation that is recognised or authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council in relation to that program, comprising Australia’s Therapeutic Goods Administration, the United States Food and Drug Administration, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency.
Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
relevant implantable medical device means an implantable medical device other than a medical device:
(a) mentioned in paragraphs 13A.1(1)(b) or (ba) of Schedule 1 to the Regulations; or
(b) to which subclause 13A.1(2) of Schedule 1 to the Regulations applies.
Note: Medical devices mentioned in paragraph 13A.1(1)(b) of Schedule 1 to the Regulations include, for example, sutures, staples, dental fillings and dental braces. The medical devices mentioned in paragraph 13A.1(1)(ba) of Schedule 1 to the Regulations are medical devices that are intended by the manufacturer to be for export only.
Singapore Health Products Act means the Health Products Act 2007 of Singapore as in force on 1 July 2022.
Singapore Register of Health Products means the Register of Health Products kept and maintained by the Health Sciences Authority of Singapore under section 34 of the Singapore Health Products Act.
Therapeutic Goods Administration means that part of the Department known as the Therapeutic Goods Administration.
UK approved body has the meaning given to “approved body” in regulation A45 of the UK Regulations.
UK Regulations means the Medical Devices Regulations 2002 (SI 2002/618), as in force in England, Wales and Scotland on 1 December 2025.
Note: The UK Regulations could in 2025 be viewed on the UK legislation website (www.legislation.gov.uk).
US FDC Act means the Federal Food, Drug, and Cosmetic Act of the United States, as in force immediately before the commencement of this instrument.
5 Kind of information—medical devices other than IVD medical devices
Class I medical devices
(1A) An application for a Class I medical device that the manufacturer intends to be supplied in a non-sterile state and that does not have a measuring function must be accompanied by the following kind of information:
(a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 1 of Part 1 of Schedule 1, which is recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document in relation to the medical device specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
(1) An application for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function must be accompanied by the following kind of information:
(a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 2 of Part 1 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
(2) To avoid doubt:
(a) for the purpose of subsection (1), an application may be accompanied by more than one document referred to in paragraph (1)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (1)(b) (if any);
(b) a document which accompanies an application in accordance with subsection (1) or (1A) must relate to the kind of device to which the application relates.
Class IIa medical devices
(3) An application for a Class IIa medical device must be accompanied by the following kind of information:
(a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
(4) To avoid doubt:
(a) an application may be accompanied by more than one document referred to in paragraph (3)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (3)(b) (if any);
(b) a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates.
Class IIb medical devices
(5) An application for a Class IIb medical device must be accompanied by the following kind of information:
(a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 3 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
(6) To avoid doubt:
(a) an application may be accompanied by more than one document referred to in paragraph (5)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (5)(b) (if any);
(b) a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates.
Class III medical devices
(7) An application for a Class III medical device must be accompanied by the following kind of information:
(a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 4 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item;
(b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item;
(c) if the application is not accompanied by a conformity assessment certificate issued by the TGA—a clinical evaluation report and the instructions for use.
(8) To avoid doubt:
(a) an application may be accompanied by more than one document referred to in paragraph (7)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (7)(b) (if any);
(b) a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.
Application of this section
(11) This section does not apply to any of the following:
(a) a medical device used for a special purpose;
(b) a medical device that is intended by the manufacturer to be for export only.
6 Kind of information—IVD medical devices
Class 1 IVD medical devices
(1A) An application for a Class 1 IVD medical device must be accompanied by the following kind of information:
(a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 1A of Schedule 2, which is recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document in relation to the medical device specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
(1B) To avoid doubt, a document which accompanies the application in accordance with subsection (1A) must relate to the kind of device to which the application relates.
Class 2 IVD medical devices
(1) An application for a Class 2 IVD medical device must be accompanied by the following kind of information:
(a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 1 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item; and
(c) if the application is accompanied by the information specified in item 2 or 2B in the table in Part 1 of Schedule 2—evidence to demonstrate compliance with Article 110(3c) of the EU IVD regulation.
(2) To avoid doubt:
(a) an application may be accompanied by more than one document referred to in paragraph (1)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (1)(b) (if any);
(b) a document which accompanies the application in accordance with subsection (1) must relate to the kind of device to which the application relates.
Class 3 IVD medical devices
(3) An application for a Class 3 IVD medical device must be accompanied by the following kind of information:
(a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item; and
(c) if the application is accompanied by the information specified in item 3, 3B or 4 in the table in Part 2 of Schedule 2—evidence to demonstrate compliance with Article 110(3c) of the EU IVD regulation.
(4) To avoid doubt:
(a) an application may be accompanied by more than one document referred to in paragraph (3)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (3)(b) (if any);
(b) a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates.
Class 4 IVD medical devices
(5) An application for a Class 4 IVD medical device must be accompanied by the following kind of information:
(a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 3 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item; and
(c) if the application is accompanied by the information specified in item 3 or 4 in the table in Part 3 of Schedule 2—evidence to demonstrate compliance with Article 110(3c) of the EU IVD regulation.
(6) To avoid doubt:
(a) an application may be accompanied by more than one document referred to in paragraph (5)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (5)(b) (if any);
(b) a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates.
Class 4 in-house IVD medical devices
(7) An application for a Class 4 in-house IVD medical device must be accompanied by the following kind of information:
(a) a conformity assessment document or other evidence that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 4 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
(8) To avoid doubt:
(a) an application may be accompanied by more than one document referred to in paragraph (7)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (7)(b) (if any);
(b) a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.
Application of this section
(9) This section does not apply to any of the following:
(a) a medical device used for a special purpose;
(b) a medical device that is intended by the manufacturer to be for export only.
6A Kind of information—medical devices intended for export only
(1) An application for a medical device that is intended by the manufacturer to be for export only, including an IVD medical device, must be accompanied by the following kind of information:
(a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Schedule 2A, which is recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document in relation to the medical device specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
(2) To avoid doubt, a document which accompanies the application in accordance with this section must relate to the kind of device to which the application relates.
Application of this section
(3) This section does not apply to a medical device used for a special purpose.
7 Kind of information—medical devices used for a special purpose that are a system or procedure pack
(1A) An application for a medical device used for a special purpose that is a system or procedure pack and:
(a) classified under the Regulations as a Class I medical device that:
(i) does not have a measuring function; and
(ii) the manufacturer intends to be supplied in a non-sterile state; or
(b) classified under the Regulations as a Class 1 IVD medical device; or
(c) intended by the manufacturer to be for export only;
must be accompanied by the following kind of information:
(d) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 1 of Part 1 of Schedule 3, which is recognised by the regulatory authority in column 2 of that item; and
(e) a conformity assessment document in relation to each medical device contained in the system or procedure pack specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
(1) An application for a medical device used for a special purpose that is a system or procedure pack, other than a medical device that is mentioned in subsection (1A), must be accompanied by the following kind of information:
(a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 2 of Part 1 of Schedule 3, which is recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document in relation to each medical device contained in the system or procedure pack specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
Additional information required where the manufacturer intends the medical device used for a special purpose to be supplied in a sterile state
(2) An application for a medical device to which subsection (1) applies, and which the manufacturer intends to be supplied in a sterile state, must also be accompanied by the following kind of information:
(a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 3, which is issued or recognised by the regulatory authority in column 2 of that item; and
(b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
(3) To avoid doubt:
(a) an application may be accompanied by more than one document referred to in paragraph (2)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (2)(b) (if any);
(b) a document which accompanies the application in accordance with this section must relate to the kind of device to which the application relates.
8 Alternative kinds of information
Medical devices other than IVD medical devices
(1) An application for a medical device other than an IVD medical device may be accompanied by the kind of information determined under section 5 that relates to an application for a kind of medical device that is classified at a higher level than the medical device concerned, rather than the kind of information determined for that class of medical device under that section.
IVD medical devices
(2) An application for an IVD medical device may be accompanied by the kind of information determined under section 6 that relates to an application for a kind of medical device that is classified at a higher level than the medical device concerned, rather than the kind of information determined for that class of medical device under that section.
Note: The kind of information determined under sections 5 and 6 relate to the minimum conformity assessment procedures that the manufacturer must apply to a kind of device of that classification.
9 Classes of medical device for which accompanying information is not determined
To avoid doubt, no kind of information is determined for the purposes of subsection 41FDB(7) for an application in relation to a medical device in one of the following classifications:
(a) an in-house IVD medical device other than a Class 4 in-house IVD medical device;
(b) a medical device used for a special purpose that is not a system or procedure pack.
Note: In effect, this means that no information must accompany applications in relation to these classifications.
10 Form of information—all medical devices
All information that accompanies an application in accordance with section 5, 6 or 7 must be:
(a) legible; and
(b) either of the following:
(i) in English; or
(ii) if it is not in English—be accompanied by a certified translation into English.
Schedule 1—Medical devices other than IVD medical devices
Note: See section 5.
Part 1—Class I medical devices
Division 1—Class I medical devices that are intended to be supplied in a non-sterile state and do not have a measuring function
Column 1Item
Column 2Regulatory authority
Column 3Declaration of conformity in relation to the medical device
Column 4Conformity assessment document relating to the medical device
1
Therapeutic Goods Administration
a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations
Division 2—Class I medical devices that are intended to be supplied in a sterile state or have a measuring function
Column 1Item
Column 2Regulatory authority
Column 3Conformity assessment document relating to manufacturer’s quality management system
Column 4Conformity assessment document relating to product assessment
1
Therapeutic Goods Administration
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:(a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function):(i) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or(ii) Part 4 (production quality assurance procedures);(b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state):(i) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part;(ii) Part 3 (verification procedures);(iii) Part 4 (production quality assurance procedures); or(iv) Part 5 (product quality assurance procedures)
2
a notified body within the meaning of Council Directive 93/42/EEC
(a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function), either of the following:(i) a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or(ii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;(b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state), one of the following:(i) a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part;(ii) an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;(iii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or(iv) a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC
3
a notified body within the meaning of Council Directive 90/385/EEC
(a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function), either of the following:(i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or(ii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;(b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state), one of the following:(i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC;(ii) an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or(iii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC
4
a notified body within the meaning of the EU medical devices regulation
for a medical device that the manufacturer intends to be supplied in a sterile state and/or that has a measuring function, either of the following:(a) an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation; or(b) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation
5
recognised or authorised auditing organisation
for a medical device that the manufacturer intends to be supplied in a sterile state and/or that has a measuring functiona MDSAP certificate
6
a UK approved body
(a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function)—either of the following:(i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 in applied Directive 90/385;(ii) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385;(b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state)—one of the following:(i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 in applied Directive 90/385;(ii) a verification certificate of conformity issued under Annex 4 in applied Directive 90/385;(iii) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385
7
a UK approved body
(a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function)—either of the following:(i) a full quality assurance system certificate or other document issued under Annex II in applied Directive 93/42, excluding section 4 of that Annex;(ii) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42;(b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state)—one of the following:(i) a full quality assurance system certificate or other document issued under Annex II in applied Directive 93/42, excluding section 4 of that Annex;(ii) a verification certificate of conformity issued under Annex IV in applied Directive 93/42;(iii) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42;(iv) a product quality assurance certificate or other document issued under Annex VI in applied Directive 93/42
Part 2—Class IIa medical devices
<table cellspacing="0" cellpadding="0" style="width:417.4pt; border-collapse:collapse"><thead><tr><td style="width:44.15pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p><p class="TableHeading"><span>Item</span></p></td><td colspan="2" style="width:80.05pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Regulatory authority</span></p></td><td colspan="2" style="width:135.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="TableHeading"><span>Conformity assessment document relating to manufacturer’s quality management system</span></p></td><td colspan="3" style="width:110.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span>Column 4</span></p><p class="TableHeading" style="margin-left:5.45pt"><span>Conformity assessment document relating to product assessment</span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr></thead><tbody><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">Therapeutic Goods Administration</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:</span></p><p class="Tabletext" style="margin-left:20.5pt; text-indent:-20.5pt"><span>(a)</span><span style="width:9.4pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state:</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>Part 4 (production quality assurance procedures);</span></p><p class="Tabletext" style="margin-left:20.5pt; text-indent:-20.5pt"><span>(b)</span><span style="width:8.84pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state:</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part;</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>Part 3 (verification procedures);</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(iii)Part 4 (production quality assurance procedures); or</span></p><p class="Tabletext" style="margin-left:34.7pt; text-indent:-14.2pt"><span>(iv)Part 5 (product quality assurance procedures)</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a notified body within the meaning of Council Directive 93/42/EEC</span></p><p class="TableHeading"><span style="font-weight:normal"></span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:20.5pt; text-indent:-20.5pt"><span>(a)</span><span style="width:9.4pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following:</span></p><ol class="awlist1" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or</span></li><li class="Tabletext" style="margin-left:31.35pt; text-indent:-14.2pt"><span style="width:1.98pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;</span></li></ol><p class="Tabletext" style="margin-left:20.5pt; text-indent:-20.5pt"><span>(b)</span><span style="width:8.84pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:</span></p><ol class="awlist2" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36.1pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part;</span></li><li class="Tabletext" style="margin-left:32.25pt; text-indent:-14.15pt"><span style="width:1.93pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;</span></li><li class="Tabletext" style="margin-left:32.25pt; text-indent:-14.15pt; list-style-position:inside"><span style="width:2.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or</span></li><li class="Tabletext" style="margin-left:32.25pt; text-indent:-14.15pt; list-style-position:inside"><span style="width:3.46pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC</span></li></ol></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a notified body within the meaning of Council Directive 90/385/EEC</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><ol class="awlist3" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following:</span></li></ol><ol class="awlist4" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or</span></li><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:5.78pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;</span></li></ol><ol class="awlist5" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:</span></li></ol><ol class="awlist6" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC;</span></li><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:5.78pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or</span></li><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:3pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC</span></li></ol></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a notified body within the meaning of the EU medical devices regulation</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span></span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a notified body within the meaning of the EU medical devices regulation</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.95pt"><span>(i)</span><span style="width:6.51pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation;</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.95pt"><span>(i)</span><span style="width:6.51pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.95pt"><span>(ii)</span><span style="width:3.73pt; text-indent:0pt; display:inline-block"> </span><span>an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:26.05pt"><span style="font-weight:bold"></span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Japan’s Ministry</span><br><span>of Health, Labour and Welfare or</span><br><span>the Japanese Pharmaceuticals and Medical Devices Agency</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><ol class="awlist7" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a MDSAP certificate; or</span></li><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a quality management system certificate for the purposes of the Japanese PMD Act</span></li></ol></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">either of the following:</span></p><ol class="awlist8" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:26.15pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a pre-market certification issued under the Japanese PMD Act; or</span></li><li class="Tabletext" style="margin-left:26.15pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a pre-market approval issued under the Japanese PMD Act</span></li></ol></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">Health Canada</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk169446516"><span>a MDSAP certificate</span></a></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">a Class II medical device licence issued under the Canadian medical devices regulations</span></p></td><td style="vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">United States</span><br><span style="font-weight:normal">Food and Drug Administration</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">for medical devices that are not exempted, by the United States Food and Drug Administration, from section 510(k) requirements—either of the following:</span></p><ol class="awlist9" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:26.15pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a determination of substantial equivalence made with respect to a notification submitted under section</span><span> </span><span>510(k) of the US FDC Act; or</span></li><li class="Tabletext" style="margin-left:26.15pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an order granting a request for classification under section 513 of the US FDC Act (a</span><span> </span><span>De Novo classification request)</span></li></ol></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8A</span></p></td><td colspan="3" style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">United States Food</span><span style="font-weight:normal"> </span><span style="font-weight:normal">and Drug Administration</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">for medical devices that are exempted, by the United States Food and Drug Administration, from section 510(k) requirements—a statement that includes the device name or description, regulation number and submission type under United States Food and Drug Administration requirements</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td colspan="2" style="width:80.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">Health Sciences Authority of Singapore</span></p></td><td colspan="2" style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class B medical device</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal"></span></p></td><td style="border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; vertical-align:top"></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td></tr><tr><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:79.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a UK approved body</span></p></td><td colspan="5" style="width:140pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state—either of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(i)</span><span style="width:5.91pt; text-indent:0pt; display:inline-block"> </span><span>a full quality assurance system certificate or other document issued under Annex II in applied Directive</span><span> </span><span>93/42, excluding section 4 of that Annex;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(ii)</span><span style="width:3.13pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate or other document issued under Annex</span><span> </span><span>V in applied Directive</span><span> </span><span>93/42;</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state—one of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(i)</span><span style="width:5.91pt; text-indent:0pt; display:inline-block"> </span><span>a full quality assurance system certificate or other document issued under Annex II in applied Directive</span><span> </span><span>93/42, excluding section</span><span> </span><span>4 of that Annex;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(ii)</span><span style="width:3.13pt; text-indent:0pt; display:inline-block"> </span><span>a verification certificate of conformity issued under Annex</span><span> </span><span>IV in applied Directive</span><span> </span><span>93/42;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(iii)</span><span style="width:0.35pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate or other document issued under Annex</span><span> </span><span>V in applied Directive</span><span> </span><span>93/42;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(iv)</span><span style="width:0.91pt; text-indent:0pt; display:inline-block"> </span><span>a product quality assurance certificate or other document issued under Annex</span><span> </span><span>VI in applied Directive</span><span> </span><span>93/42</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal"></span></p></td></tr><tr style="height:453pt"><td style="width:44.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>11</span></p></td><td style="width:79.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal">a UK approved body</span></p></td><td colspan="5" style="width:140pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state—either of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(i)</span><span style="width:5.91pt; text-indent:0pt; display:inline-block"> </span><span>a complete quality assurance system certificate or other document issued under section 3 of Annex</span><span> </span><span>2 in applied Directive</span><span> </span><span>90/385;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(ii)</span><span style="width:3.13pt; text-indent:0pt; display:inline-block"> </span><span>an assurance of production quality certificate or other document issued under Annex</span><span> </span><span>5 in applied Directive</span><span> </span><span>90/385;</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state—one of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(i)</span><span style="width:5.91pt; text-indent:0pt; display:inline-block"> </span><span>a complete quality assurance system certificate or other document issued under section</span><span> </span><span>3 of Annex</span><span> </span><span>2 in applied Directive</span><span> </span><span>90/385;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(ii)</span><span style="width:3.13pt; text-indent:0pt; display:inline-block"> </span><span>a verification certificate of conformity issued under Annex</span><span> </span><span>4 in applied Directive</span><span> </span><span>90/385;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(iii)</span><span style="width:0.35pt; text-indent:0pt; display:inline-block"> </span><span>an assurance of production quality certificate or other document issued under Annex</span><span> </span><span>5 in applied Directive</span><span> </span><span>90/385</span></p></td><td colspan="3" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span style="font-weight:normal"></span></p></td></tr><tr style="height:0pt"><td style="width:54.95pt"></td><td style="width:90.15pt"></td><td style="width:0.7pt"></td><td style="width:0.45pt"></td><td style="width:146.05pt"></td><td style="width:0.45pt"></td><td style="width:3.15pt"></td><td style="width:117.9pt"></td><td style="width:0.45pt"></td><td style="width:3.15pt"></td></tr></tbody></table>
Part 3—Class IIb medical devices
<table cellspacing="0" cellpadding="0" style="width:416.05pt; border-collapse:collapse"><thead><tr><td style="width:44.4pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1 Item</span></p></td><td style="width:80.6pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Regulatory authority</span></p></td><td style="width:135.75pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="TableHeading"><span>Conformity assessment document relating to manufacturer’s quality management system</span></p></td><td colspan="2" style="width:110.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span>Column 4</span></p><p class="TableHeading" style="margin-left:5.45pt"><span>Conformity assessment document relating to product assessment</span></p></td><td style="vertical-align:top"></td></tr></thead><tbody><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Therapeutic Goods Administration</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Therapeutic Goods Administration</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:</span></p><ol class="awlist10" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for a medical device that the manufacturer intends to be supplied in a sterile state:</span></li></ol><ol class="awlist11" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:31.35pt; text-indent:-14.2pt"><span style="width:4.76pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>Part 4 (production quality assurance procedures);</span></li></ol><ol class="awlist12" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state:</span></li></ol><ol class="awlist13" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>Part 3 (verification procedures);</span></li><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:5.78pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>Part 4 (production quality assurance procedures); or</span></li><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:3pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>Part 5 (product quality assurance procedures)</span></li></ol></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part</span><span style="font-weight:normal"> </span><span style="font-weight:normal">2 of Schedule 3 to the Regulations (type examination procedures)</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Council Directive 93/42/EEC</span></p><p class="Tabletext"><span></span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Council Directive 93/42/EEC</span></p><p class="Tabletext"><span></span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><ol class="awlist14" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for a medical device that the manufacturer intends to be supplied in a sterile state:</span></li></ol><ol class="awlist15" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;</span></li></ol><ol class="awlist16" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:</span></li></ol><ol class="awlist17" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:8.56pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;</span></li><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:5.78pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or</span></li><li class="Tabletext" style="margin-left:36pt; text-indent:-18pt"><span style="width:3pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC</span></li></ol></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">an EC type-examination certificate issued under Annex III of Council Directive 93/42/EEC</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Council Directive 90/385/EEC</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of the EU medical devices regulation</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">for a relevant implantable medical device—an EU technical documentation assessment certificate issued under Chapter II of Annex IX of the EU medical devices regulation</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of the EU medical devices regulation</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.95pt"><span>(i)</span><span style="width:6.51pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation;</span></p><p class="Tabletext" style="margin-left:19.85pt; text-indent:-19.85pt; page-break-inside:avoid"><span>(b)</span><span style="width:8.19pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.95pt"><span>(i)</span><span style="width:6.51pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or</span></p><p class="Tabletext" style="margin-left:33.85pt; text-indent:-14.2pt"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">an EU type-examination certificate issued under Annex X of the EU medical devices regulation</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Japan’s Ministry</span><br><span>of Health, Labour and Welfare or</span><br><span>the Japanese Pharmaceuticals</span><br><span>and Medical Devices Agency</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><ol class="awlist18" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a MDSAP certificate; or</span></li><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a quality management system certificate for the purposes of the Japanese PMD Act</span></li></ol></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">either of the following:</span></p><ol class="awlist19" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:25.25pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a pre-market certification issued under the Japanese PMD Act; or</span></li><li class="Tabletext" style="margin-left:26.15pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a pre-market approval issued under the Japanese PMD Act</span></li></ol></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Health Canada</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">a Class III medical device licence issued under the Canadian medical devices regulations</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>United States</span><br><span>Food and Drug Administration</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p><p class="Tabletext"><span></span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span style="font-weight:normal">one of the following:</span></p><ol class="awlist20" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:25.25pt; text-indent:-21.25pt"><span style="width:10.15pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a determination of substantial equivalence made with respect to a notification submitted under section</span><span> </span><span>510(k) of the US FDC Act;</span></li><li class="Tabletext" style="margin-left:26.15pt; text-indent:-22.15pt"><span style="width:10.49pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an order granting a request for classification under section 513 of the US FDC Act (a</span><span> </span><span>De Novo classification request); or</span></li><li class="Tabletext" style="margin-left:26.15pt; text-indent:-22.15pt"><span style="width:11.05pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an order approving an application for premarket approval under section 515 of the US FDC Act</span></li></ol></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>11</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>United States</span><br><span>Food and Drug Administration</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an order approving an application for premarket approval under section 515 of the US FDC Act</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:18pt"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>12</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Health Sciences Authority of Singapore</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class C medical device</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:18pt"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>13</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a UK approved body</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a full quality assurance system certificate or other document issued under Annex II in applied Directive</span><span> </span><span>93/42, excluding section 4 of that Annex</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:18pt"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>14</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a UK approved body</span></p></td><td style="width:135.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a sterile state—a production quality assurance certificate or other document issued under Annex V in applied Directive</span><span> </span><span>93/42;</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>for a medical device that the manufacturer intends to be supplied in a non-sterile state—one of the following:</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.95pt"><span>(i)</span><span style="width:6.51pt; text-indent:0pt; display:inline-block"> </span><span>a verification certificate of conformity issued under Annex</span><span> </span><span>IV in applied Directive</span><span> </span><span>93/42;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.95pt"><span>(ii)</span><span style="width:3.73pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate or other document issued under Annex</span><span> </span><span>V in applied Directive</span><span> </span><span>93/42;</span></p><p class="Tabletext" style="margin-left:33.95pt; text-indent:-15.35pt"><span>(iii)</span><span style="width:0.35pt; text-indent:0pt; display:inline-block"> </span><span>a product quality assurance certificate or other document issued under Annex VI in applied Directive</span><span> </span><span>93/42</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:18pt"><span></span></p></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td></tr><tr><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>15</span></p></td><td style="width:80.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a UK approved body</span></p></td><td colspan="2" style="width:137.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a complete quality assurance system certificate or other document issued under section 3 of Annex 2</span><span> </span><span>in applied Directive</span><span> </span><span>90/385</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:18pt"><span></span></p></td></tr><tr style="height:0pt"><td style="width:55.2pt"></td><td style="width:91.4pt"></td><td style="width:146.55pt"></td><td style="width:1.4pt"></td><td style="width:120.1pt"></td><td style="width:1.4pt"></td></tr></tbody></table>
Part 4—Class III medical devices
Column 1 Item
Column 2Regulatory authority
Column 3Conformity assessment document relating to manufacturer’s quality management system
Column 4Conformity assessment document relating to product assessment
1
Therapeutic Goods Administration
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design)
2
Therapeutic Goods Administration
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:for a medical device that the manufacturer intends to be supplied in a sterile state:Part 4 (production quality assurance procedures);for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:Part 3 (verification procedures); orPart 4 (production quality assurance procedures)
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures)
3
a notified body within the meaning of Council Directive 93/42/EEC
a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Annex
an EC design-examination certificate issued under section 4 of Annex II of Council Directive 93/42/EEC
4
a notified body within the meaning of Council Directive 93/42/EEC
for a medical device that the manufacturer intends to be supplied in a sterile state:a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC; ora production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC
an EC type-examination certificate issued under Annex III of Council Directive 93/42/EEC
5
a notified body within the meaning of Council Directive 90/385/EEC
a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC
an EC design examination certificate issued under section 4 of Annex 2 of Council Directive 90/385/EEC
6
a notified body within the meaning of Council Directive 90/385/EEC
for a medical device that the manufacturer intends to be supplied in a sterile state:an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; oran assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC
an EC type-examination certificate issued under Annex 3 of Council Directive 90/385/EEC
7
a notified body within the meaning of the EU medical devices regulation
an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation
an EU technical documentation assessment certificate issued under Chapter II of Annex IX of the EU medical devices regulation
8
a notified body within the meaning of the EU medical devices regulation
(a) for a medical device that the manufacturer intends to be supplied in a sterile state:(i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation;(b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:(i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or(ii) an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation
an EU type-examination certificate issued under Annex X of the EU medical devices regulation
9
Japan’s Ministryof Health, Labour and Welfare orthe Japanese Pharmaceuticalsand Medical Devices Agency
either of the following:a MDSAP certificate; ora quality management system certificate for the purposes of the Japanese PMD Act
a pre-market approval issued under the Japanese PMD Act
10
Health Canada
a MDSAP certificate
a Class IV medical device licence issued under the Canadian medical devices regulations
11
United StatesFood and Drug Administration
a MDSAP certificate
one of the following:(a) a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act;(b) an order approving an application for premarket approval under section 515 of the US FDC Act
12
United StatesFood and Drug Administration
an order approving an application for premarket approval under section 515 of the US FDC Act
13
Health Sciences Authority of Singapore
an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class D medical device
14
a UK approved body
a full quality assurance system certificate or other document issued under Annex II in applied Directive 93/42, excluding section 4 of that Annex
a design examination certificate issued under section 4 of Annex II in applied Directive 93/42
15
a UK approved body
(a) for a medical device that the manufacturer intends to be supplied in a sterile state—a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42;(b) for a medical device that the manufacturer intends to be supplied in a non-sterile state—either of the following:(i) a verification certificate of conformity issued under Annex IV in applied Directive 93/42;(ii) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42
a type‑examination certificate issued under Annex III in applied Directive 93/42
16
a UK approved body
a complete quality assurance system certificate or other document issued under section 3 of Annex 2 in applied Directive 90/385
a design examination certificate issued under section 4 of Annex 2 in applied Directive 90/385
17
a UK approved body
for a medical device that the manufacturer intends to be supplied in a sterile state—an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385;(b) for a medical device that the manufacturer intends to be supplied in a non-sterile state—either of the following:(i) a verification certificate of conformity issued under Annex 4 in applied Directive 90/385;(ii) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385
a type‑examination certificate issued under Annex 3 in applied Directive 90/385
Schedule 2—IVD medical devices
Note: See section 6.
Part 1A—Class 1 IVD medical devices
Column 1Item
Column 2Regulatory authority
Column 3Declaration of conformity in relation to the medical device
Column 4Conformity assessment document relating to the medical device
1
Therapeutic Goods Administration
a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations
Part 1—Class 2 IVD medical devices
<table cellspacing="0" cellpadding="0" style="border-collapse:collapse"><thead><tr style="height:39.7pt"><td style="width:44.35pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1 Item</span></p></td><td style="width:80.25pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Regulatory authority</span></p></td><td colspan="2" style="width:135.85pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="Tabletext"><span style="font-weight:bold">Conformity assessment document relating to manufacturer’s quality management system</span></p></td><td colspan="2" style="width:110.75pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 4</span></p><p class="TableHeading"><span>Conformity assessment document relating to product assessment</span></p></td><td style="vertical-align:top"></td></tr></thead><tbody><tr style="height:56.7pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:80.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Therapeutic Goods Administration</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:</span></p><ol class="awlist35" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or</span></li><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>Part 4 (production quality assurance procedures)</span></li></ol></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td colspan="2" style="width:80.65pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Directive 98/79/EC</span></p></td><td colspan="2" style="width:136.2pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 1</span><span> </span><span>January 2030—one of the following:</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(a)</span><span style="width:8.9pt; text-indent:0pt; display:inline-block"> </span><span>a full quality assurance system certificate or other document issued under section 3 of Annex IV of Directive 98/79/EC;</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(b)</span><span style="width:8.34pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate or other document issued under Annex VII of Directive 98/79/EC</span></p></td><td colspan="2" style="width:111.25pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2A</span></p></td><td colspan="2" style="width:80.65pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Directive 98/79/EC</span></p></td><td colspan="2" style="width:136.2pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 26 May 2027</span><span style="font-family:Symbol, serif"></span><span>a document certifying compliance with ISO</span><span> </span><span>13485</span></p></td><td colspan="2" style="width:111.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26</span><span> </span><span>May</span><span> </span><span>2022</span></p></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2B</span></p></td><td colspan="2" style="width:80.65pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Directive 98/79/EC</span></p></td><td colspan="2" style="width:136.2pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 1 January 2030</span><span style="font-family:Symbol, serif"></span><span>an EU declaration of conformity made by the manufacturer under Annex</span><span> </span><span>III of Directive 98/79/EC before 26</span><span> </span><span>May</span><span> </span><span>2022</span></p></td><td colspan="2" style="width:111.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr style="height:56.7pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:80.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of the EU IVD regulation</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for </span><a id="_Hlk169456127"><span>an IVD medical device for self</span><span>‑</span><span>testing or an IVD medical device for point of care testing</span></a><span>—</span><a id="_Hlk169456146"><span>an assessment of technical documentation referred to in section 5.1 of Annex IX of the EU IVD regulation</span></a></p></td><td style="vertical-align:top"></td></tr><tr style="height:56.7pt"><td style="width:44.35pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:80.25pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Health Canada</span></p></td><td colspan="2" style="width:135.85pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>a MDSAP certificate</span></p></td><td colspan="2" style="width:110.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a Class II medical device licence issued under the Canadian medical devices regulations</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:56.7pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:80.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>United States</span><br><span>Food and Drug Administration</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a determination of substantial equivalence made with respect to a notification submitted under section</span><span> </span><span>510(k) of the</span><br><span>US FDC Act</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:56.7pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:80.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>recognised or authorised auditing organisation</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:80.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an IAF accredited conformity assessment body</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 26 May 2027</span><span style="font-family:Symbol, serif"></span><span>a document certifying compliance with ISO</span><span> </span><span>13485</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26</span><span> </span><span>May</span><span> </span><span>2022</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:80.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Health Sciences Authority of Singapore</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class B IVD</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td colspan="2" style="width:80.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Japan’s Ministry of Health, Labour and Welfare or the Japanese Pharmaceuticals and Medical Devices Agency</span></p></td><td colspan="2" style="width:136.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p><span style="font-size:10pt">either of the following:</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(a)</span><span style="width:8.9pt; text-indent:0pt; display:inline-block"> </span><span>a MDSAP certificate; or</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(b)</span><span style="width:8.34pt; text-indent:0pt; display:inline-block"> </span><span>a quality management system certificate for the purposes of the Japanese PMD Act</span></p></td><td colspan="2" style="width:111.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p><span style="font-size:10pt">for an IVD medical device for self</span><span style="font-size:10pt">‑</span><span style="font-size:10pt">testing or an IVD medical device for point of care testing—one or more of the following:</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(a)</span><span style="width:8.9pt; text-indent:0pt; display:inline-block"> </span><span>a pre-market certification issued under the Japanese PMD Act;</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(b)</span><span style="width:8.34pt; text-indent:0pt; display:inline-block"> </span><span>a pre-market approval issued under the Japanese PMD Act</span></p></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="page-break-after:avoid"><span>11</span></p></td><td colspan="2" style="width:80.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="page-break-after:avoid"><span>a UK approved body</span></p></td><td colspan="2" style="width:136.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>a full quality assurance system certificate or other document issued under section 3 of Annex IV in applied Directive</span><span> </span><span>98/79;</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt; page-break-after:avoid"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate or other document issued under Annex VII in applied Directive</span><span> </span><span>98/79</span></p></td><td colspan="2" style="width:111.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="page-break-after:avoid"><span style="font-size:10pt"></span></p></td></tr><tr style="height:0pt"><td style="width:55.15pt"></td><td style="width:91.05pt"></td><td style="width:0.4pt"></td><td style="width:146.25pt"></td><td style="width:0.75pt"></td><td style="width:120.8pt"></td><td style="width:1.25pt"></td></tr></tbody></table>
Part 2—Class 3 IVD medical devices
<table cellspacing="0" cellpadding="0" style="width:415.8pt; border-collapse:collapse"><thead><tr style="height:36.85pt"><td style="width:44.35pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1 Item</span></p></td><td style="width:80.3pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Regulatory authority</span></p></td><td colspan="2" style="width:135.85pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="Tabletext"><span style="font-weight:bold">Conformity assessment document relating to manufacturer’s quality management system</span></p></td><td colspan="2" style="width:110.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 4</span></p><p class="TableHeading"><span>Conformity assessment document relating to product assessment</span></p></td><td style="vertical-align:top"></td></tr></thead><tbody><tr style="height:56.7pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:80.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Therapeutic Goods Administration</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part)</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td></tr><tr style="height:56.7pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:80.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Therapeutic Goods Administration</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 4 of Schedule 3 to the Regulations (production quality assurance procedures)</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures)</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td colspan="2" style="width:80.65pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Directive 98/79/EC</span></p></td><td colspan="2" style="width:136.3pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>for an application submitted before 1 January 2029—a full quality assurance system certificate or other document issued under section 3 of Annex</span><span> </span><span>IV of Directive 98/79/EC</span></p></td><td colspan="2" style="width:111.3pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3A</span></p></td><td colspan="2" style="width:80.65pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="background-color:#ffffff">a notified body within the meaning of Directive 98/79/EC</span></p></td><td colspan="2" style="width:136.3pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="background-color:#ffffff">for an application submitted before 26 May 2026</span><span style="font-family:Symbol, serif; background-color:#ffffff"></span><span style="background-color:#ffffff">a document certifying compliance with ISO</span><span style="background-color:#ffffff"> </span><span style="background-color:#ffffff">13485</span></p></td><td colspan="2" style="width:111.3pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26</span><span> </span><span>May</span><span> </span><span>2022</span></p></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3B</span></p></td><td colspan="2" style="width:80.65pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Directive 98/79/EC</span></p></td><td colspan="2" style="width:136.3pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 1 January 2029</span><span style="font-family:Symbol, serif"></span><span>an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26</span><span> </span><span>May</span><span> </span><span>2022</span></p></td><td colspan="2" style="width:111.3pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr style="height:56.7pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:80.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Directive 98/79/EC</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 1 January 2029—a production quality assurance certificate or other document issued under Annex</span><span> </span><span>VII of Directive 98/79/EC</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 1</span><span> </span><span>January</span><span> </span><span>2029—an EC type-examination certificate issued under Annex</span><span> </span><span>V of Directive 98/79/EC</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:56.7pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:80.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of the EU IVD regulation</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>one of the following:</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(a)</span><span style="width:8.9pt; text-indent:0pt; display:inline-block"> </span><span>for an IVD medical device for self</span><span>‑</span><span>testing or an IVD medical device for point of care testing—an assessment of technical documentation set out in section 5.1 of Annex IX of the EU IVD regulation; or</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(b)</span><span style="width:8.34pt; text-indent:0pt; display:inline-block"> </span><span>for an IVD companion diagnostic—an assessment of technical documentation set out in section 5.2 of Annex IX of the EU IVD regulation; or</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(c)</span><span style="width:8.9pt; text-indent:0pt; display:inline-block"> </span><span>for other IVD medical devices—the assessment of technical documentation as set out in section 4 of Annex IX of the EU IVD regulation for at least one representative device in a generic device group</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:56.7pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:80.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of the EU IVD regulation</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU production quality assurance certificate issued under Annex XI of the EU IVD regulation, excluding section 5 of that Annex</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU type-examination certificate issued under Annex X of the EU IVD regulation</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:56.7pt"><td style="width:44.35pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:80.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Health Canada</span></p></td><td colspan="2" style="width:135.85pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>a MDSAP certificate</span></p></td><td colspan="2" style="width:110.7pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a Class III medical device licence issued under the Canadian medical devices regulations</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:56.7pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:80.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>United States</span><br><span>Food and Drug Administration</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><ol class="awlist36" style="margin:0pt; padding-left:0pt"><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>a determination of substantial equivalence made with respect to a notification submitted under section</span><span> </span><span>510(k) of the US FDC Act; or</span></li><li class="Tabletext" style="margin-left:18pt; text-indent:-18pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>an order approving an application for premarket approval under section 515 of the US FDC Act</span></li></ol></td><td style="vertical-align:top"></td></tr><tr style="height:17pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:80.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>United States</span><br><span>Food and Drug Administration</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an order approving an application for premarket approval under section 515 of the US FDC Act</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an order approving an application for premarket approval under section 515 of the US FDC Act</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:80.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>recognised or authorised auditing organisation</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="vertical-align:top"></td></tr><tr style="height:17pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>12</span></p></td><td style="width:80.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="background-color:#ffffff">an IAF accredited conformity assessment body</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="background-color:#ffffff">for an application submitted before 26 May 2026</span><span style="font-family:Symbol, serif; background-color:#ffffff"></span><span style="background-color:#ffffff">a document certifying compliance with ISO</span><span style="background-color:#ffffff"> </span><span style="background-color:#ffffff">13485</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26</span><span> </span><span>May</span><span> </span><span>2022</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:17pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>13</span></p></td><td style="width:80.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="background-color:#ffffff">Health Sciences Authority of Singapore</span></p></td><td colspan="2" style="width:135.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="background-color:#ffffff">an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class C IVD</span></p></td><td colspan="2" style="width:110.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td></tr><tr style="height:17pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>14</span></p></td><td colspan="2" style="width:80.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk169450150"><span>Japan’s Ministry of Health, Labour and Welfare or the Japanese Pharmaceuticals and Medical Devices Agency</span></a></p></td><td colspan="2" style="width:136.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p><span style="font-size:10pt">either of the following:</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(a)</span><span style="width:8.9pt; text-indent:0pt; display:inline-block"> </span><span>a MDSAP certificate; or</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(b)</span><span style="width:8.34pt; text-indent:0pt; display:inline-block"> </span><span>a quality management system certificate for the purposes of the Japanese PMD Act</span></p></td><td colspan="2" style="width:111.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p><span style="font-size:10pt">for an IVD medical device for self</span><span style="font-size:10pt">‑</span><span style="font-size:10pt">testing or an IVD medical device for point of care testing</span><span>—either </span><span style="font-size:10pt">of the following:</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(a)</span><span style="width:8.9pt; text-indent:0pt; display:inline-block"> </span><span>a pre-market certification issued under the Japanese PMD Act; or</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(b)</span><span style="width:8.34pt; text-indent:0pt; display:inline-block"> </span><span>a pre-market approval issued under the Japanese PMD Act</span></p></td></tr><tr style="height:8.5pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>15</span></p></td><td colspan="2" style="width:80.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a UK approved body</span></p></td><td colspan="2" style="width:136.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a full quality assurance system certificate or other document issued under section 3 of Annex</span><span> </span><span>IV in applied Directive</span><span> </span><span>98/79</span></p></td><td colspan="2" style="width:111.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p><span style="font-size:10pt"></span></p></td></tr><tr style="height:17pt"><td style="width:44.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>16</span></p></td><td colspan="2" style="width:80.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a UK approved body</span></p></td><td colspan="2" style="width:136.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a production quality assurance certificate or other document issued under Annex VII in applied Directive</span><span> </span><span>98/79</span></p></td><td colspan="2" style="width:111.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a type</span><span>‑</span><span>examination certificate issued under Annex V in applied Directive</span><span> </span><span>98/79</span></p></td></tr><tr style="height:0pt"><td style="width:55.15pt"></td><td style="width:91.1pt"></td><td style="width:0.35pt"></td><td style="width:146.3pt"></td><td style="width:0.8pt"></td><td style="width:120.7pt"></td><td style="width:1.4pt"></td></tr></tbody></table>
Part 3—Class 4 IVD medical devices
<table cellspacing="0" cellpadding="0" style="width:415.5pt; border-collapse:collapse"><thead><tr style="height:36.85pt"><td style="width:44.4pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1 Item</span></p></td><td style="width:80.5pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Regulatory authority</span></p></td><td style="width:135.7pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="Tabletext"><span style="font-weight:bold">Conformity assessment document relating to manufacturer’s quality management system</span></p></td><td colspan="2" style="width:110.75pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 4</span></p><p class="TableHeading"><span>Conformity assessment document relating to product assessment</span></p></td><td style="vertical-align:top"></td></tr></thead><tbody><tr style="height:56.7pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Therapeutic Goods Administration</span></p></td><td style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design)</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:56.7pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Therapeutic Goods Administration</span></p></td><td style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 4 of Schedule 3 to the Regulations (production quality assurance procedures)</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part</span><span> </span><span>2 of Schedule 3 to the Regulations (type examination procedures)</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:42.5pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Directive 98/79/EC</span></p></td><td style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 1 January 2028—a full quality assurance system certificate or other document issued under section</span><span> </span><span>3 of Annex</span><span> </span><span>IV of Directive 98/79/EC</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 1</span><span> </span><span>January</span><span> </span><span>2028—an EC design-examination certificate issued under Annex</span><span> </span><span>IV of Directive 98/79/EC</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:42.5pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Directive 98/79/EC</span></p></td><td style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 1 January 2028—a production quality assurance certificate or other document issued under Annex</span><span> </span><span>VII of Directive 98/79/ EC</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for an application submitted before 1</span><span> </span><span>January</span><span> </span><span>2028— an EC type-examination certificate issued under Annex</span><span> </span><span>V of Directive 98/79/EC</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:42.5pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a</span><span style="letter-spacing:-0.05pt"> </span><span>notified</span><span style="letter-spacing:0.1pt"> </span><span>body</span><span style="letter-spacing:0.05pt"> </span><span>within</span><span style="letter-spacing:-0.5pt"> </span><span>the</span><span style="letter-spacing:-0.35pt"> </span><span>meaning</span><span style="letter-spacing:-2.35pt"> </span><span>of the EU IVD</span><span style="letter-spacing:0.05pt"> </span><span>regulation</span></p></td><td style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an</span><span style="letter-spacing:-0.25pt"> </span><span>EU</span><span style="letter-spacing:-0.15pt"> </span><span>quality</span><span style="letter-spacing:-0.1pt"> </span><span>management</span><span style="letter-spacing:-0.05pt"> </span><span>system </span><span style="letter-spacing:-2.35pt"></span><span>certificate issued under Chapter I</span><span style="letter-spacing:0.05pt"> </span><span>of Annex IX of the EU IVD</span><span style="letter-spacing:0.05pt"> </span><span>regulation</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU design-examination</span><span style="letter-spacing:-2.35pt"> </span><span>certificate issued under</span><span style="letter-spacing:0.05pt"> Chapter II of </span><span>Annex</span><span style="letter-spacing:-0.15pt"> I</span><span>X</span><span style="letter-spacing:-0.1pt"> </span><span>of</span><span style="letter-spacing:-0.2pt"> </span><span>the</span><span style="letter-spacing:-0.1pt"> </span><span>EU IVD regulation</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:42.5pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a</span><span style="letter-spacing:-0.05pt"> </span><span>notified</span><span style="letter-spacing:0.1pt"> </span><span>body</span><span style="letter-spacing:0.05pt"> </span><span>within</span><span style="letter-spacing:-0.5pt"> </span><span>the</span><span style="letter-spacing:-0.35pt"> </span><span>meaning</span><span style="letter-spacing:-2.35pt"> </span><span>of the EU IVD</span><span style="letter-spacing:0.05pt"> </span><span>regulation</span></p></td><td style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU production quality</span><span style="letter-spacing:0.05pt"> </span><span>assurance certificate issued under</span><span style="letter-spacing:-2.4pt"> </span><span>Annex XI of the EU IVD</span><span style="letter-spacing:0.05pt"> </span><span>regulation</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an EU type-examination</span><span style="letter-spacing:-2.35pt"> </span><span>certificate issued under</span><span style="letter-spacing:0.05pt"> </span><span>Annex</span><span style="letter-spacing:-0.15pt"> </span><span>X</span><span style="letter-spacing:-0.1pt"> </span><span>of</span><span style="letter-spacing:-0.2pt"> </span><span>the</span><span style="letter-spacing:-0.1pt"> </span><span>EU</span><span style="letter-spacing:-0.1pt"> </span><span>IVD</span><span style="letter-spacing:-2.35pt"> </span><span>regulation</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:42.5pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Japan’s Ministry of Health, Labour and Welfare or the Japanese Pharmaceuticals and Medical Devices Agency</span></p></td><td style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p><span style="font-size:10pt">either of the following:</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(a)</span><span style="width:8.9pt; text-indent:0pt; display:inline-block"> </span><span>a MDSAP certificate; or</span></p><p class="Tabletext" style="margin-left:20pt; text-indent:-20pt"><span>(b)</span><span style="width:8.34pt; text-indent:0pt; display:inline-block"> </span><span>a quality management system certificate for the purposes of the Japanese PMD Act</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a pre-market approval issued under the Japanese PMD Act</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:42.5pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>United States Food and Drug Administration</span></p></td><td style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk169520230"><span>an order approving an application for premarket approval under section 515 of the US FDC Act</span></a></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>an order approving an application for premarket approval under section 515 of the US FDC Act</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:42.5pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Health Canada</span></p></td><td style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk169520255"><span>a MDSAP certificate</span></a></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk169520265"><span>a Class IV medical device licence issued under Canadian medical device regulations</span></a></p></td><td style="vertical-align:top"></td></tr><tr style="height:42.5pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Health Sciences Authority of Singapore</span></p></td><td style="width:135.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk169520299"><span>an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class D IVD</span></a></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td></tr><tr style="height:8.5pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>11</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a UK approved body</span></p></td><td colspan="2" style="width:136.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a full quality assurance system certificate or other document issued under section 3 of Annex</span><span> </span><span>IV in applied Directive</span><span> </span><span>98/79</span></p></td><td colspan="2" style="width:111.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a design</span><span>‑</span><span>examination certificate issued under Annex IV in applied Directive</span><span> </span><span>98/79</span></p></td></tr><tr style="height:17pt"><td style="width:44.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>12</span></p></td><td style="width:80.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a UK approved body</span></p></td><td colspan="2" style="width:136.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a production quality assurance certificate or other document issued under Annex VII in applied</span><span> </span><span>Directive</span><span> </span><span>98/79</span></p></td><td colspan="2" style="width:111.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a type</span><span>‑</span><span>examination certificate issued under Annex V in applied Directive</span><span> </span><span>98/79</span></p></td></tr><tr style="height:0pt"><td style="width:55.2pt"></td><td style="width:91.3pt"></td><td style="width:146.5pt"></td><td style="width:0.6pt"></td><td style="width:120.95pt"></td><td style="width:0.95pt"></td></tr></tbody></table>
Part 4—Class 4 in-house IVD medical devices
Column 1 Item
Column 2Regulatory authority
Column 3Conformity assessment document or other evidence relating to manufacturer’s quality management system
Column 4Conformity assessment document relating to product assessment
1
Therapeutic Goods Administration
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design)
2
Therapeutic Goods Administration
a manufacturing licence referred to in subparagraph 6B.3(2)(a)(ii) of Schedule 3 to the Regulations
3
Therapeutic Goods Administration
a certificate of accreditation issued by NATA of the kind referred to in subparagraph 6B.3(2)(b)(i) of Schedule 3 to the Regulations
Schedule 2A—Medical devices intended for export only
Note: See section 6A.
Column 1Item
Column 2Regulatory authority
Column 3Declaration of conformity in relation to the medical device
Column 4Conformity assessment document relating to the medical device
1
Therapeutic Goods Administration
a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations
Schedule 3—Medical devices used for a special purpose that are a system or procedure pack
Note: See section 7.
Part 1—All medical devices used for a special purpose that are a system or procedure pack
Division 1—System or procedure packs that are Class I medical devices intended to be supplied in a non-sterile state and that do not have a measuring function, Class 1 IVD medical devices, or intended for export only
Column 1Item
Column 2Regulatory authority
Column 3Declaration of conformity in relation to the system or procedures pack
Column 4Conformity assessment document in relation to each medical device
1
Therapeutic Goods Administration
a declaration of conformity made by the manufacturer under clause 7.5 of Schedule 3 to the Regulations
Division 2—System or procedure packs that are not Class I medical devices intended to be supplied in a non-sterile state and that do not have a measuring function, not Class 1 IVD medical devices, or not intended for export only
Column 1Item
Column 2Regulatory authority
Column 3Declaration of conformity in relation to the system or procedure pack
Column 4Conformity assessment document in relation to each medical device
1
Therapeutic Goods Administration
a declaration of conformity made by the manufacturer under clause 7.5 of Schedule 3 to the Regulations
a conformity assessment document in relation to each medical device contained in the system or procedure pack
Part 2—System or procedure packs that are intended to be supplied in a sterile state and that are not Class 1 IVD medical devices, or not intended for export only
<table cellspacing="0" cellpadding="0" style="width:421.25pt; border-collapse:collapse"><thead><tr><td style="width:44.55pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p><p class="TableHeading"><span>Item</span></p></td><td style="width:80.4pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Regulatory authority</span></p></td><td colspan="2" style="width:135.6pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="TableHeading"><span>Conformity assessment document relating to manufacturer’s quality management system</span></p></td><td colspan="2" style="width:110.75pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="margin-left:5.45pt"><span>Column 4</span></p><p class="TableHeading" style="margin-left:5.45pt"><span>Conformity assessment document relating to product assessment</span></p></td><td style="vertical-align:top"></td></tr></thead><tbody><tr><td style="width:44.55pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:80.4pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Therapeutic Goods Administration</span></p></td><td colspan="2" style="width:135.6pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>Part 4 (production quality assurance procedures)</span></p></td><td colspan="2" style="width:110.75pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:3.4pt"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:80.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Council Directive 93/42/EEC</span></p><p class="Tabletext"><span></span></p></td><td colspan="2" style="width:135.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>either of the following:</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:3.4pt"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:80.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of Council Directive 90/385/EEC</span></p></td><td colspan="2" style="width:135.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>either of the following:</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-15.95pt"><span>(a)</span><span style="width:4.85pt; text-indent:0pt; display:inline-block"> </span><span>a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-15.95pt"><span>(b)</span><span style="width:4.29pt; text-indent:0pt; display:inline-block"> </span><span>an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:3.4pt"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:80.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a notified body within the meaning of the EU medical devices regulation</span></p></td><td colspan="2" style="width:135.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation; or</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:3.4pt"><span></span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:44.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:80.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>recognised or authorised auditing organisation</span></p></td><td colspan="2" style="width:135.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a MDSAP certificate</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:3.4pt"><span></span></p></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td></tr><tr style="height:8.5pt"><td style="width:44.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td colspan="2" style="width:86.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a UK approved body</span></p></td><td colspan="2" style="width:136.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>a full quality assurance system certificate or other document issued under Annex II in applied Directive</span><span> </span><span>93/42, excluding section 4 of that Annex;</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>a production quality assurance certificate or other document issued under Annex V in applied Directive</span><span> </span><span>93/42</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:3.4pt"><span></span></p></td></tr><tr style="height:17pt"><td style="width:44.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td colspan="2" style="width:86.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>a UK approved body</span></p></td><td colspan="2" style="width:136.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(a)</span><span style="width:8.65pt; text-indent:0pt; display:inline-block"> </span><span>a complete quality assurance system certificate or other document issued under section</span><span> </span><span>3 of Annex</span><span> </span><span>2 in applied Directive</span><span> </span><span>90/385;</span></p><p class="Tabletext" style="margin-left:19.75pt; text-indent:-19.75pt"><span>(b)</span><span style="width:8.09pt; text-indent:0pt; display:inline-block"> </span><span>an assurance of production quality certificate or other document issued under Annex</span><span> </span><span>5 in applied Directive</span><span> </span><span>90/385</span></p></td><td colspan="2" style="width:110.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:3.4pt"><span></span></p></td></tr><tr style="height:0pt"><td style="width:55.35pt"></td><td style="width:91.2pt"></td><td style="width:6.05pt"></td><td style="width:140.35pt"></td><td style="width:6.75pt"></td><td style="width:114.8pt"></td><td style="width:6.75pt"></td></tr></tbody></table>