{"id":"F2018L01410","name":"Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018","slug":"therapeutic-goods-medical-devices-information-that-must-accompany-application-for-inclusion-determin","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":98098,"registerId":"commonwealth-F2018L01410-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsections 41FDB(7) and 41FDB(8) of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:\n\n (a) conformity assessment certificate;\n (b) conformity assessment document;\n (c) conformity assessment procedures;\n (d) included in the Register;\n (e) kind, in relation to a medical device;\n (f) medical device;\n (g) system or procedure pack.\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> 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.\n\n 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.\n 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.\n 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.\n\n> 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.\n\n> 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.\n\n Class 1 IVD medical device has the same meaning as in the Regulations.\n Class 2 IVD medical device has the same meaning as in the Regulations.\n Class 3 IVD medical device has the same meaning as in the Regulations.\n Class 4 IVD medical device has the same meaning as in the Regulations.\n Class 4 in-house IVD medical device has the same meaning as in the Regulations.\n\n> Class I medical device has the same meaning as in the Regulations.\n\n Class IIa medical device has the same meaning as in the Regulations.\n Class IIb medical device has the same meaning as in the Regulations.\n Class III medical device has the same meaning as in the Regulations.\n 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.\n 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.\n 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.\n 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.\n 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.\n 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.\n\ngeneric device group has the same meaning as in the EU IVD regulation.\n\n 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.\n implantable medical device has the same meaning as in the Regulations.\n in-house IVD medical device has the same meaning as in the Regulations.\n\ninstructions for use has the same meaning as in the Regulations.\n\n ISO 13485 means International Standard ISO 13485:2016 Medical devicesQuality management systemsRequirements 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.\n\nNote: ISO 13485 is published at: https://www.iso.org.\n\nIVD companion diagnostic has the same meaning as in the Regulations.\n\n IVD medical device, or in vitro diagnostic medical device, has the same meaning as in the Regulations.\n\nIVD medical device for self-testing has the same meaning as in the Regulations.\n\n 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.\n manufacturing licence has the same meaning as in the Regulations.\n 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.\n measuring function has the same meaning as in the Regulations.\n medical device used for a special purpose has the same meaning as in the Regulations.\n NATA has the same meaning as in the Regulations.\n 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.\n\npoint of care testing has the same meaning as in the Regulations.\n\n 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.\n 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.\n Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n relevant implantable medical device means an implantable medical device other than a medical device:\n (a) mentioned in paragraphs 13A.1(1)(b) or (ba) of Schedule 1 to the Regulations; or\n (b) to which subclause 13A.1(2) of Schedule 1 to the Regulations applies.\n\n> 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.\n\n Singapore Health Products Act means the Health Products Act 2007 of Singapore as in force on 1 July 2022.\n 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.\n Therapeutic Goods Administration means that part of the Department known as the Therapeutic Goods Administration.\n UK approved body has the meaning given to “approved body” in regulation A45 of the UK Regulations.\n UK Regulations means the Medical Devices Regulations 2002 (SI 2002/618), as in force in England, Wales and Scotland on 1 December 2025.\n\n> Note: The UK Regulations could in 2025 be viewed on the UK legislation website (www.legislation.gov.uk).\n\n 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.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Kind of information—medical devices other than IVD medical devices","content":"#### 5 Kind of information—medical devices other than IVD medical devices\n\n Class I medical devices\n (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:\n (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\n (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.\n (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:\n (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\n (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.\n (2) To avoid doubt:\n (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);\n (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.\n Class IIa medical devices\n (3) An application for a Class IIa medical device must be accompanied by the following kind of information:\n (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\n (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.\n (4) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates.\n Class IIb medical devices\n (5) An application for a Class IIb medical device must be accompanied by the following kind of information:\n (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\n (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.\n (6) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates.\n Class III medical devices\n (7) An application for a Class III medical device must be accompanied by the following kind of information:\n (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;\n (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;\n (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.\n (8) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.\n\nApplication of this section\n\n(11) This section does not apply to any of the following:\n\n(a) a medical device used for a special purpose;\n\n(b) a medical device that is intended by the manufacturer to be for export only.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Kind of information—IVD medical devices","content":"#### 6 Kind of information—IVD medical devices\n\n Class 1 IVD medical devices\n (1A) An application for a Class 1 IVD medical device must be accompanied by the following kind of information:\n (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\n (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.\n (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.\n Class 2 IVD medical devices\n (1) An application for a Class 2 IVD medical device must be accompanied by the following kind of information:\n (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\n (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\n (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.\n (2) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (1) must relate to the kind of device to which the application relates.\n Class 3 IVD medical devices\n (3) An application for a Class 3 IVD medical device must be accompanied by the following kind of information:\n (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\n (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\n (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.\n (4) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates.\n Class 4 IVD medical devices\n (5) An application for a Class 4 IVD medical device must be accompanied by the following kind of information:\n (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\n (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\n (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.\n (6) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates.\n Class 4 in-house IVD medical devices\n (7) An application for a Class 4 in-house IVD medical device must be accompanied by the following kind of information:\n (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\n (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.\n (8) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.\n\nApplication of this section\n\n(9) This section does not apply to any of the following:\n\n(a) a medical device used for a special purpose;\n\n (b) a medical device that is intended by the manufacturer to be for export only.","sortOrder":4},{"sectionNumber":"6A","sectionType":"section","heading":"Kind of information—medical devices intended for export only","content":"#### 6A Kind of information—medical devices intended for export only\n\n(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:\n\n(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\n\n(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.\n\n(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.\n\nApplication of this section\n\n(3) This section does not apply to a medical device used for a special purpose.","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Kind of information—medical devices used for a special purpose that are a system or procedure pack","content":"#### 7 Kind of information—medical devices used for a special purpose that are a system or procedure pack\n\n(1A) An application for a medical device used for a special purpose that is a system or procedure pack and:\n\n(a) classified under the Regulations as a Class I medical device that:\n\n(i) does not have a measuring function; and\n\n(ii) the manufacturer intends to be supplied in a non-sterile state; or\n\n(b) classified under the Regulations as a Class 1 IVD medical device; or\n\n(c) intended by the manufacturer to be for export only;\n\nmust be accompanied by the following kind of information:\n\n(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\n\n(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.\n\n(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:\n\n(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\n\n(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.\n\n Additional information required where the manufacturer intends the medical device used for a special purpose to be supplied in a sterile state\n (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:\n (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\n (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.\n (3) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with this section must relate to the kind of device to which the application relates.","sortOrder":6},{"sectionNumber":"8","sectionType":"section","heading":"Alternative kinds of information","content":"#### 8 Alternative kinds of information\n\n Medical devices other than IVD medical devices\n (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.\n IVD medical devices\n (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.\n\n> 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.","sortOrder":7},{"sectionNumber":"9","sectionType":"section","heading":"Classes of medical device for which accompanying information is not determined","content":"#### 9 Classes of medical device for which accompanying information is not determined\n\nTo 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:\n\n(a) an in-house IVD medical device other than a Class 4 in-house IVD medical device;\n\n(b) a medical device used for a special purpose that is not a system or procedure pack.\n\nNote: In effect, this means that no information must accompany applications in relation to these classifications.","sortOrder":8},{"sectionNumber":"10","sectionType":"section","heading":"Form of information—all medical devices","content":"#### 10 Form of information—all medical devices\n\n All information that accompanies an application in accordance with section 5, 6 or 7 must be:\n (a) legible; and\n (b) either of the following:\n (i) in English; or\n (ii) if it is not in English—be accompanied by a certified translation into English.\n\nSchedule 1—Medical devices other than IVD medical devices\n\nNote: See section 5.","sortOrder":9},{"sectionNumber":"Part 1","sectionType":"part","heading":"Class I medical devices","content":"#### 1 Name\n\n This instrument is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.\n\n#### 3 Authority\n\n This instrument is made under subsections 41FDB(7) and 41FDB(8) of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:\n\n (a) conformity assessment certificate;\n (b) conformity assessment document;\n (c) conformity assessment procedures;\n (d) included in the Register;\n (e) kind, in relation to a medical device;\n (f) medical device;\n (g) system or procedure pack.\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> 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.\n\n 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.\n 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.\n 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.\n\n> 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.\n\n> 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.\n\n Class 1 IVD medical device has the same meaning as in the Regulations.\n Class 2 IVD medical device has the same meaning as in the Regulations.\n Class 3 IVD medical device has the same meaning as in the Regulations.\n Class 4 IVD medical device has the same meaning as in the Regulations.\n Class 4 in-house IVD medical device has the same meaning as in the Regulations.\n\n> Class I medical device has the same meaning as in the Regulations.\n\n Class IIa medical device has the same meaning as in the Regulations.\n Class IIb medical device has the same meaning as in the Regulations.\n Class III medical device has the same meaning as in the Regulations.\n 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.\n 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.\n 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.\n 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.\n 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.\n 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.\n\ngeneric device group has the same meaning as in the EU IVD regulation.\n\n 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.\n implantable medical device has the same meaning as in the Regulations.\n in-house IVD medical device has the same meaning as in the Regulations.\n\ninstructions for use has the same meaning as in the Regulations.\n\n ISO 13485 means International Standard ISO 13485:2016 Medical devicesQuality management systemsRequirements 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.\n\nNote: ISO 13485 is published at: https://www.iso.org.\n\nIVD companion diagnostic has the same meaning as in the Regulations.\n\n IVD medical device, or in vitro diagnostic medical device, has the same meaning as in the Regulations.\n\nIVD medical device for self-testing has the same meaning as in the Regulations.\n\n 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.\n manufacturing licence has the same meaning as in the Regulations.\n 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.\n measuring function has the same meaning as in the Regulations.\n medical device used for a special purpose has the same meaning as in the Regulations.\n NATA has the same meaning as in the Regulations.\n 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.\n\npoint of care testing has the same meaning as in the Regulations.\n\n 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.\n 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.\n Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n relevant implantable medical device means an implantable medical device other than a medical device:\n (a) mentioned in paragraphs 13A.1(1)(b) or (ba) of Schedule 1 to the Regulations; or\n (b) to which subclause 13A.1(2) of Schedule 1 to the Regulations applies.\n\n> 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.\n\n Singapore Health Products Act means the Health Products Act 2007 of Singapore as in force on 1 July 2022.\n 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.\n Therapeutic Goods Administration means that part of the Department known as the Therapeutic Goods Administration.\n UK approved body has the meaning given to “approved body” in regulation A45 of the UK Regulations.\n UK Regulations means the Medical Devices Regulations 2002 (SI 2002/618), as in force in England, Wales and Scotland on 1 December 2025.\n\n> Note: The UK Regulations could in 2025 be viewed on the UK legislation website (www.legislation.gov.uk).\n\n 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.\n\n#### 5 Kind of information—medical devices other than IVD medical devices\n\n Class I medical devices\n (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:\n (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\n (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.\n (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:\n (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\n (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.\n (2) To avoid doubt:\n (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);\n (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.\n Class IIa medical devices\n (3) An application for a Class IIa medical device must be accompanied by the following kind of information:\n (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\n (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.\n (4) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates.\n Class IIb medical devices\n (5) An application for a Class IIb medical device must be accompanied by the following kind of information:\n (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\n (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.\n (6) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates.\n Class III medical devices\n (7) An application for a Class III medical device must be accompanied by the following kind of information:\n (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;\n (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;\n (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.\n (8) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.\n\nApplication of this section\n\n(11) This section does not apply to any of the following:\n\n(a) a medical device used for a special purpose;\n\n(b) a medical device that is intended by the manufacturer to be for export only.\n\n#### 6 Kind of information—IVD medical devices\n\n Class 1 IVD medical devices\n (1A) An application for a Class 1 IVD medical device must be accompanied by the following kind of information:\n (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\n (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.\n (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.\n Class 2 IVD medical devices\n (1) An application for a Class 2 IVD medical device must be accompanied by the following kind of information:\n (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\n (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\n (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.\n (2) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (1) must relate to the kind of device to which the application relates.\n Class 3 IVD medical devices\n (3) An application for a Class 3 IVD medical device must be accompanied by the following kind of information:\n (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\n (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\n (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.\n (4) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates.\n Class 4 IVD medical devices\n (5) An application for a Class 4 IVD medical device must be accompanied by the following kind of information:\n (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\n (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\n (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.\n (6) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates.\n Class 4 in-house IVD medical devices\n (7) An application for a Class 4 in-house IVD medical device must be accompanied by the following kind of information:\n (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\n (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.\n (8) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.\n\nApplication of this section\n\n(9) This section does not apply to any of the following:\n\n(a) a medical device used for a special purpose;\n\n (b) a medical device that is intended by the manufacturer to be for export only.\n\n#### 6A Kind of information—medical devices intended for export only\n\n(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:\n\n(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\n\n(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.\n\n(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.\n\nApplication of this section\n\n(3) This section does not apply to a medical device used for a special purpose.\n\n#### 7 Kind of information—medical devices used for a special purpose that are a system or procedure pack\n\n(1A) An application for a medical device used for a special purpose that is a system or procedure pack and:\n\n(a) classified under the Regulations as a Class I medical device that:\n\n(i) does not have a measuring function; and\n\n(ii) the manufacturer intends to be supplied in a non-sterile state; or\n\n(b) classified under the Regulations as a Class 1 IVD medical device; or\n\n(c) intended by the manufacturer to be for export only;\n\nmust be accompanied by the following kind of information:\n\n(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\n\n(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.\n\n(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:\n\n(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\n\n(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.\n\n Additional information required where the manufacturer intends the medical device used for a special purpose to be supplied in a sterile state\n (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:\n (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\n (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.\n (3) To avoid doubt:\n (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);\n (b) a document which accompanies the application in accordance with this section must relate to the kind of device to which the application relates.\n\n#### 8 Alternative kinds of information\n\n Medical devices other than IVD medical devices\n (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.\n IVD medical devices\n (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.\n\n> 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.\n\n#### 9 Classes of medical device for which accompanying information is not determined\n\nTo 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:\n\n(a) an in-house IVD medical device other than a Class 4 in-house IVD medical device;\n\n(b) a medical device used for a special purpose that is not a system or procedure pack.\n\nNote: In effect, this means that no information must accompany applications in relation to these classifications.\n\n#### 10 Form of information—all medical devices\n\n All information that accompanies an application in accordance with section 5, 6 or 7 must be:\n (a) legible; and\n (b) either of the following:\n (i) in English; or\n (ii) if it is not in English—be accompanied by a certified translation into English.\n\nSchedule 1—Medical devices other than IVD medical devices\n\nNote: See section 5.\n\n## Part 1—Class I medical devices\n\n### Division 1—Class I medical devices that are intended to be supplied in a non-sterile state and do not have a measuring function\n\n| Column 1Item | Column 2Regulatory authority | Column 3Declaration of conformity in relation to the medical device | Column 4Conformity assessment document relating to the medical device |\n| ------------ | -------------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------- |\n| 1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations | |\n\n### Division 2—Class I medical devices that are intended to be supplied in a sterile state or have a measuring function\n\n| Column 1Item | Column 2Regulatory authority | Column 3Conformity assessment document relating to manufacturer’s quality management system | Column 4Conformity assessment document relating to product assessment |\n| ------------ | ----------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------- |\n| 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) | |\n| 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 | |\n| 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 | |\n| 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 | |\n| 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 functiona MDSAP certificate | |\n| 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 | |\n| 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 | |\n\n \n\n## Part 2—Class IIa medical devices\n\n```html\n

Column 1

Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity 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:

(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 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, either of the following:

  1. 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
  2. a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;

(b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:

  1. 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;
  2. an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;
  3. a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or
  4. 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

  1. for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following:
  1. a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or
  2. an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;
  1. for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:
  1. a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC;
  2. an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or
  3. 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

an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation

5

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

6

Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals and Medical Devices Agency

either of the following:

  1. a MDSAP certificate; or
  2. a quality management system certificate for the purposes of the Japanese PMD Act

either of the following:

  1. a pre-market certification issued under the Japanese PMD Act; or
  2. a pre-market approval issued under the Japanese PMD Act

7

Health Canada

a MDSAP certificate

a Class II medical device licence issued under the Canadian medical devices regulations

8

United States
Food and Drug Administration

a MDSAP certificate

for medical devices that are not exempted, by the United States Food and Drug Administration, from section 510(k) requirements—either of the following:

  1. a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act; or
  2. an order granting a request for classification under section 513 of the US FDC Act (a De Novo classification request)

8A

United States Food and Drug Administration

a MDSAP certificate

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

9

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class B medical device

10

a UK approved body

(a) for a medical device that the manufacturer intends to be supplied in a sterile state—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 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

11

a UK approved body

(a) for a medical device that the manufacturer intends to be supplied in a sterile state—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 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

\n```\n\n \n\n## Part 3—Class IIb medical devices\n\n```html\n

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity 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

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:

  1. for a medical device that the manufacturer intends to be supplied in a sterile state:
  1. Part 4 (production quality assurance procedures);
  1. for a medical device that the manufacturer intends to be supplied in a non-sterile state:
  1. Part 3 (verification procedures);
  2. Part 4 (production quality assurance procedures); or
  3. Part 5 (product 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 Part

4

a notified body within the meaning of Council Directive 93/42/EEC

  1. for a medical device that the manufacturer intends to be supplied in a sterile state:
  1. a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;
  1. for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:
  1. an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;
  2. a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or
  3. a product quality assurance certificate or other document issued under Annex VI 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

6

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

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

7

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

8

Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals
and Medical Devices Agency

either of the following:

  1. a MDSAP certificate; or
  2. a quality management system certificate for the purposes of the Japanese PMD Act

either of the following:

  1. a pre-market certification issued under the Japanese PMD Act; or
  2. a pre-market approval issued under the Japanese PMD Act

9

Health Canada

a MDSAP certificate

a Class III medical device licence issued under the Canadian medical devices regulations

10

United States
Food and Drug Administration

a MDSAP certificate

one of the following:

  1. a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act;
  2. an order granting a request for classification under section 513 of the US FDC Act (a De Novo classification request); or
  3. an order approving an application for premarket approval under section 515 of the US FDC Act

11

United States
Food and Drug Administration

an order approving an application for premarket approval under section 515 of the US FDC Act

12

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class C medical device

13

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

14

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—one 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;

(iii) a product quality assurance certificate or other document issued under Annex VI in applied Directive 93/42

15

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

\n```\n\n \n\n## Part 4—Class III medical devices\n\n| 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 |\n| ------------- | ------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 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) |\n| 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) |\n| 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 |\n| 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 |\n| 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 |\n| 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 |\n| 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 |\n| 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 |\n| 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 |\n| 10 | Health Canada | a MDSAP certificate | a Class IV medical device licence issued under the Canadian medical devices regulations |\n| 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 |\n| 12 | United StatesFood and Drug Administration | an order approving an application for premarket approval under section 515 of the US FDC Act | |\n| 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 | |\n| 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 |\n| 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 |\n| 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 |\n| 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 |\n\n \n\nSchedule 2—IVD medical devices\n\nNote: See section 6.\n\n## Part 1A—Class 1 IVD medical devices\n\n| Column 1Item | Column 2Regulatory authority | Column 3Declaration of conformity in relation to the medical device | Column 4Conformity assessment document relating to the medical device |\n| ------------ | -------------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------- |\n| 1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations | |\n\n \n\n## Part 1—Class 2 IVD medical devices\n\n```html\n

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity 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:

  1. Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or
  2. Part 4 (production quality assurance procedures)

2

a notified body within the meaning of Directive 98/79/EC

for an application submitted before 1 January 2030—one of the following:

(a) a full quality assurance system certificate or other document issued under section 3 of Annex IV of Directive 98/79/EC;

(b) a production quality assurance certificate or other document issued under Annex VII of Directive 98/79/EC

2A

a notified body within the meaning of Directive 98/79/EC

for an application submitted before 26 May 2027a document certifying compliance with ISO 13485

an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26 May 2022

2B

a notified body within the meaning of Directive 98/79/EC

for an application submitted before 1 January 2030an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26 May 2022

3

a notified body within the meaning of the EU IVD regulation

an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation

for an IVD medical device for self‑testing or an IVD medical device for point of care testing—an assessment of technical documentation referred to in section 5.1 of Annex IX of the EU IVD regulation

4

Health Canada

a MDSAP certificate

a Class II medical device licence issued under the Canadian medical devices regulations

5

United States
Food and Drug Administration

a MDSAP certificate

a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the
US FDC Act

6

recognised or authorised auditing organisation

a MDSAP certificate

8

an IAF accredited conformity assessment body

for an application submitted before 26 May 2027a document certifying compliance with ISO 13485

an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26 May 2022

9

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class B IVD

10

Japan’s Ministry of Health, Labour and Welfare or the Japanese Pharmaceuticals and Medical Devices Agency

either of the following:

(a) a MDSAP certificate; or

(b) a quality management system certificate for the purposes of the Japanese PMD Act

for an IVD medical device for self‑testing or an IVD medical device for point of care testing—one or more of the following:

(a) a pre-market certification issued under the Japanese PMD Act;

(b) a pre-market approval issued under the Japanese PMD Act

11

a UK approved body

either of the following:

(a) a full quality assurance system certificate or other document issued under section 3 of Annex IV in applied Directive 98/79;

(b) a production quality assurance certificate or other document issued under Annex VII in applied Directive 98/79

\n```\n\n \n\n## Part 2—Class 3 IVD medical devices\n\n```html\n

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity 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)

2

Therapeutic Goods Administration

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)

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 Directive 98/79/EC

for an application submitted before 1 January 2029—a full quality assurance system certificate or other document issued under section 3 of Annex IV of Directive 98/79/EC

3A

a notified body within the meaning of Directive 98/79/EC

for an application submitted before 26 May 2026a document certifying compliance with ISO 13485

an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26 May 2022

3B

a notified body within the meaning of Directive 98/79/EC

for an application submitted before 1 January 2029an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26 May 2022

4

a notified body within the meaning of Directive 98/79/EC

for an application submitted before 1 January 2029—a production quality assurance certificate or other document issued under Annex VII of Directive 98/79/EC

for an application submitted before 1 January 2029—an EC type-examination certificate issued under Annex V of Directive 98/79/EC

5

a notified body within the meaning of the EU IVD regulation

an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation

one of the following:

(a) for an IVD medical device for self‑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

(b) 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

(c) 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

6

a notified body within the meaning of the EU IVD regulation

an EU production quality assurance certificate issued under Annex XI of the EU IVD regulation, excluding section 5 of that Annex

an EU type-examination certificate issued under Annex X of the EU IVD regulation

7

Health Canada

a MDSAP certificate

a Class III medical device licence issued under the Canadian medical devices regulations

8

United States
Food and Drug Administration

a MDSAP certificate

either of the following:

  1. a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act; or
  2. an order approving an application for premarket approval under section 515 of the US FDC Act

9

United States
Food and Drug Administration

an order approving an application for premarket approval under section 515 of the US FDC Act

an order approving an application for premarket approval under section 515 of the US FDC Act

10

recognised or authorised auditing organisation

a MDSAP certificate

12

an IAF accredited conformity assessment body

for an application submitted before 26 May 2026a document certifying compliance with ISO 13485

an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26 May 2022

13

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class C IVD

14

Japan’s Ministry of Health, Labour and Welfare or the Japanese Pharmaceuticals and Medical Devices Agency

either of the following:

(a) a MDSAP certificate; or

(b) a quality management system certificate for the purposes of the Japanese PMD Act

for an IVD medical device for self‑testing or an IVD medical device for point of care testing—either of the following:

(a) a pre-market certification issued under the Japanese PMD Act; or

(b) a pre-market approval issued under the Japanese PMD Act

15

a UK approved body

a full quality assurance system certificate or other document issued under section 3 of Annex IV in applied Directive 98/79

16

a UK approved body

a production quality assurance certificate or other document issued under Annex VII in applied Directive 98/79

a type‑examination certificate issued under Annex V in applied Directive 98/79

\n```\n\n \n\n## Part 3—Class 4 IVD medical devices\n\n```html\n

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity 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 Part 4 of Schedule 3 to the Regulations (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 Directive 98/79/EC

for an application submitted before 1 January 2028—a full quality assurance system certificate or other document issued under section 3 of Annex IV of Directive 98/79/EC

for an application submitted before 1 January 2028—an EC design-examination certificate issued under Annex IV of Directive 98/79/EC

4

a notified body within the meaning of Directive 98/79/EC

for an application submitted before 1 January 2028—a production quality assurance certificate or other document issued under Annex VII of Directive 98/79/ EC

for an application submitted before 1 January 2028— an EC type-examination certificate issued under Annex V of Directive 98/79/EC

5

a notified body within the meaning of the EU IVD regulation

an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation

an EU design-examination certificate issued under Chapter II of Annex IX of the EU IVD regulation

6

a notified body within the meaning of the EU IVD regulation

an EU production quality assurance certificate issued under Annex XI of the EU IVD regulation

an EU type-examination certificate issued under Annex X of the EU IVD regulation

7

Japan’s Ministry of Health, Labour and Welfare or the Japanese Pharmaceuticals and Medical Devices Agency

either of the following:

(a) a MDSAP certificate; or

(b) a quality management system certificate for the purposes of the Japanese PMD Act

a pre-market approval issued under the Japanese PMD Act

8

United States Food and Drug Administration

an order approving an application for premarket approval under section 515 of the US FDC Act

an order approving an application for premarket approval under section 515 of the US FDC Act

9

Health Canada

a MDSAP certificate

a Class IV medical device licence issued under Canadian medical device regulations

10

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class D IVD

11

a UK approved body

a full quality assurance system certificate or other document issued under section 3 of Annex IV in applied Directive 98/79

a design‑examination certificate issued under Annex IV in applied Directive 98/79

12

a UK approved body

a production quality assurance certificate or other document issued under Annex VII in applied Directive 98/79

a type‑examination certificate issued under Annex V in applied Directive 98/79

\n```\n\n \n\n## Part 4—Class 4 in-house IVD medical devices\n\n| 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 |\n| ------------- | -------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 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) |\n| 2 | Therapeutic Goods Administration | a manufacturing licence referred to in subparagraph 6B.3(2)(a)(ii) of Schedule 3 to the Regulations | |\n| 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 | |\n\n \n\nSchedule 2A—Medical devices intended for export only\n\nNote: See section 6A.\n\n| Column 1Item | Column 2Regulatory authority | Column 3Declaration of conformity in relation to the medical device | Column 4Conformity assessment document relating to the medical device |\n| ------------ | -------------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------- |\n| 1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations | |\n\n \n\nSchedule 3—Medical devices used for a special purpose that are a system or procedure pack\n\nNote: See section 7.\n\n## Part 1—All medical devices used for a special purpose that are a system or procedure pack\n\n### 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\n\n| 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 |\n| ------------ | -------------------------------- | ------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------- |\n| 1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 7.5 of Schedule 3 to the Regulations | |\n\n### 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\n\n| 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 |\n| ------------ | -------------------------------- | ------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------- |\n| 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 |\n\n \n\n## 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\n\n```html\n

Column 1

Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity 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) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or

(b) Part 4 (production quality assurance procedures)

2

a notified body within the meaning of Council Directive 93/42/EEC

either of the following:

(a) 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

(b) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;

3

a notified body within the meaning of Council Directive 90/385/EEC

either of the following:

(a) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or

(b) 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

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

a MDSAP certificate

6

a UK approved body

either of the following:

(a) a full quality assurance system certificate or other document issued under Annex II in applied Directive 93/42, excluding section 4 of that Annex;

(b) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42

7

a UK approved body

either of the following:

(a) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 in applied Directive 90/385;

(b) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385

\n```","sortOrder":10},{"sectionNumber":"Division 1","sectionType":"division","heading":"Class I medical devices that are intended to be supplied in a non-sterile state and do not have a measuring function","content":"### Division 1—Class I medical devices that are intended to be supplied in a non-sterile state and do not have a measuring function\n\n| Column 1Item | Column 2Regulatory authority | Column 3Declaration of conformity in relation to the medical device | Column 4Conformity assessment document relating to the medical device |\n| ------------ | -------------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------- |\n| 1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations | |","sortOrder":11},{"sectionNumber":"Division 2","sectionType":"division","heading":"Class I medical devices that are intended to be supplied in a sterile state or have a measuring function","content":"### Division 2—Class I medical devices that are intended to be supplied in a sterile state or have a measuring function\n\n| Column 1Item | Column 2Regulatory authority | Column 3Conformity assessment document relating to manufacturer’s quality management system | Column 4Conformity assessment document relating to product assessment |\n| ------------ | ----------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------- |\n| 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) | |\n| 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 | |\n| 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 | |\n| 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 | |\n| 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 functiona MDSAP certificate | |\n| 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 | |\n| 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 | |","sortOrder":12},{"sectionNumber":"Part 2","sectionType":"part","heading":"Class IIa medical devices","content":"## Part 2—Class IIa medical devices\n\n```html\n

Column 1

Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity 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:

(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 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, either of the following:

  1. 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
  2. a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;

(b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:

  1. 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;
  2. an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;
  3. a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or
  4. 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

  1. for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following:
  1. a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or
  2. an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;
  1. for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:
  1. a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC;
  2. an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or
  3. 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

an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation

5

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

6

Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals and Medical Devices Agency

either of the following:

  1. a MDSAP certificate; or
  2. a quality management system certificate for the purposes of the Japanese PMD Act

either of the following:

  1. a pre-market certification issued under the Japanese PMD Act; or
  2. a pre-market approval issued under the Japanese PMD Act

7

Health Canada

a MDSAP certificate

a Class II medical device licence issued under the Canadian medical devices regulations

8

United States
Food and Drug Administration

a MDSAP certificate

for medical devices that are not exempted, by the United States Food and Drug Administration, from section 510(k) requirements—either of the following:

  1. a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act; or
  2. an order granting a request for classification under section 513 of the US FDC Act (a De Novo classification request)

8A

United States Food and Drug Administration

a MDSAP certificate

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

9

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class B medical device

10

a UK approved body

(a) for a medical device that the manufacturer intends to be supplied in a sterile state—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 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

11

a UK approved body

(a) for a medical device that the manufacturer intends to be supplied in a sterile state—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 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

\n```","sortOrder":13},{"sectionNumber":"Part 3","sectionType":"part","heading":"Class IIb medical devices","content":"## Part 3—Class IIb medical devices\n\n```html\n

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity 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

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:

  1. for a medical device that the manufacturer intends to be supplied in a sterile state:
  1. Part 4 (production quality assurance procedures);
  1. for a medical device that the manufacturer intends to be supplied in a non-sterile state:
  1. Part 3 (verification procedures);
  2. Part 4 (production quality assurance procedures); or
  3. Part 5 (product 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 Part

4

a notified body within the meaning of Council Directive 93/42/EEC

  1. for a medical device that the manufacturer intends to be supplied in a sterile state:
  1. a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;
  1. for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:
  1. an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;
  2. a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or
  3. a product quality assurance certificate or other document issued under Annex VI 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

6

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

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

7

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

8

Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals
and Medical Devices Agency

either of the following:

  1. a MDSAP certificate; or
  2. a quality management system certificate for the purposes of the Japanese PMD Act

either of the following:

  1. a pre-market certification issued under the Japanese PMD Act; or
  2. a pre-market approval issued under the Japanese PMD Act

9

Health Canada

a MDSAP certificate

a Class III medical device licence issued under the Canadian medical devices regulations

10

United States
Food and Drug Administration

a MDSAP certificate

one of the following:

  1. a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act;
  2. an order granting a request for classification under section 513 of the US FDC Act (a De Novo classification request); or
  3. an order approving an application for premarket approval under section 515 of the US FDC Act

11

United States
Food and Drug Administration

an order approving an application for premarket approval under section 515 of the US FDC Act

12

Health Sciences Authority of Singapore

an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class C medical device

13

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

14

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—one 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;

(iii) a product quality assurance certificate or other document issued under Annex VI in applied Directive 93/42

15

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

\n```","sortOrder":14},{"sectionNumber":"Part 4","sectionType":"part","heading":"Class III medical devices","content":"## Part 4—Class III medical devices\n\n| 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 |\n| ------------- | ------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 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) |\n| 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) |\n| 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 |\n| 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 |\n| 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 |\n| 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 |\n| 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 |\n| 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 |\n| 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 |\n| 10 | Health Canada | a MDSAP certificate | a Class IV medical device licence issued under the Canadian medical devices regulations |\n| 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 |\n| 12 | United StatesFood and Drug Administration | an order approving an application for premarket approval under section 515 of the US FDC Act | |\n| 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 | |\n| 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 |\n| 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 |\n| 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 |\n| 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 |\n\n \n\nSchedule 2—IVD medical devices\n\nNote: See section 6.","sortOrder":15},{"sectionNumber":"Part 1A","sectionType":"part","heading":"Class 1 IVD medical devices","content":"## Part 1A—Class 1 IVD medical devices\n\n| Column 1Item | Column 2Regulatory authority | Column 3Declaration of conformity in relation to the medical device | Column 4Conformity assessment document relating to the medical device |\n| ------------ | -------------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------- |\n| 1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations | |","sortOrder":16}],"analysis":{"kimi_summary":{"_metrics":{"completionTokens":952},"content_quality":"ok","complexity_score":9,"scope_assessment":{"changed":true,"description":"The instrument has expanded significantly from its original 2018 scope. Major additions include: (1) incorporation of the EU IVD Regulation (2017/746) and EU Medical Devices Regulation (2017/745) following Brexit; (2) addition of UK approved bodies and 'applied Directives' post-Brexit; (3) Singapore Health Products Act and Register recognition (added 2022); (4) multiple transitional provisions with sunset dates extending to 2030; (5) MDSAP certificate recognition expansion; (6) IAF accredited conformity assessment body provisions; (7) new categories for IVD companion diagnostics and point-of-care testing; (8) Article 110(3c) EU IVD regulation compliance evidence requirements. The instrument has evolved from a simple EU-Australia alignment tool to a multi-jurisdictional recognition framework covering US, Canada, Japan, EU, UK, and Singapore."},"complexity_factors":["47+ defined terms in section 4, many referencing external regulations (EU directives, UK Regulations, Japanese PMD Act, Canadian regulations, US FDC Act)","Extensive cross-referencing to the Therapeutic Goods Act 1989, Therapeutic Goods (Medical Devices) Regulations 2002, and multiple international regulatory frameworks","Multiple schedules with detailed tables (Schedules 1, 2, 2A, 3) containing itemized documentary requirements across 4 columns per table","Nested conditional logic: requirements vary by device class, sterility status, measuring function, intended use (export only, special purpose), and submission date (multiple sunset clauses for transitional provisions)","Temporal complexity: multiple cutoff dates (1 January 2028, 1 January 2029, 1 January 2030, 26 May 2026, 26 May 2027, 1 December 2024, 1 December 2025) for accepting different types of evidence","Exception layering: exclusions for special purpose devices, export-only devices, in-house IVDs, and system/procedure packs with their own sub-categories","Dual-pathway structure: separate but parallel requirements for medical devices vs. IVD (in vitro diagnostic) medical devices","Incorporation by reference of dynamic external instruments (EU regulations as in force on specific dates, UK Regulations as in force on 1 December 2025)"],"plain_english_summary":"This law sets a risk-based checklist for registering medical devices in Australia: manufacturers and sponsors must submit paperwork proving safety, quality and performance, with higher-risk devices needing fuller evidence. It affects device makers, their Australian sponsors, and the TGA.\n\nIt streamlines registration by recognizing approvals from trusted overseas regulators and MDSAP audits, allows alternative and export-only pathways, and has special rules for system/procedure packs. All submissions must be in English or include certified translations."},"flash_summary":{"complexity_score":9,"scope_assessment":{"changed":false,"description":"This Determination refines and expands the list of acceptable supporting documents and explicitly maps a wide range of recognised foreign conformity evidence to Australian application requirements. That is an implementation and harmonisation exercise rather than a change of the statutory scope: it does not add new categories of activity that fall within the Register‑inclusion power in s.41FDB of the Therapeutic Goods Act, but it does broaden the practical set of evidentiary pathways manufacturers may use. Concretely, it increases procedural breadth (more recognised foreign documents and transitional options) without altering the Act’s substantive coverage of what kinds of devices may be included. The net effect is greater procedural complexity and more cross‑jurisdictional reliance, not a substantive expansion of regulatory scope."},"complexity_factors":["Extensive number of defined terms and external references (EU medical devices regulation, EU IVD regulation, Council Directives 90/385, 93/42, 98/79, UK Regulations, US FDC Act, Japanese PMD Act, Canadian Medical Devices Regulations, Singapore Health Products Act, ISO 13485, MDSAP, IAF MLA)","Multiple Schedules and Parts: Schedule 1 (non‑IVD) with Parts 1–4, Schedule 2 (IVD) with Parts 1A–4, Schedule 2A, Schedule 3 with multiple Parts and Divisions — effectively 4 schedules + numerous subdivisions","Large tabular mapping: dozens of table entries mapping device classes to acceptable conformity documents and recognised issuing authorities (many rows per class and per authority)","Numerous conditional and alternative pathways: for many items applicants may provide more than one type of document, or the document appropriate to a higher risk class (see section 8 and repeated “may be accompanied by more than one document” language)","Nested exceptions and ‘to avoid doubt’ clauses repeated across sections (multiple layers of 'if/then' and cross‑references)","Temporal/transitional provisions: several date‑limited entries (e.g. acceptance of certain EU declarations or ISO compliance before 26 May 2022/2026/2027, and cutoffs like 1 Jan 2028/2029/2030) increase conditional complexity","Cross‑references to the parent Act and to multiple items in the Therapeutic Goods (Medical Devices) Regulations 2002 (for example to Schedule 3 Parts and clauses such as clause 1.6), requiring simultaneous reading of at least two instruments","Multiple device classifications to track: Class I, IIa, IIb, III; Class 1–4 IVD; Class 4 in‑house IVD; system/procedure packs; special‑purpose devices; export‑only devices","Obligations that trigger different ancillary requirements (e.g. clinical evaluation report and instructions for use only in specific absence of a TGA conformity certificate — s.5(7)(c))","High verification burden for administrator: documents must be “issued or recognised by” particular foreign authorities and must “relate to the kind of device” (repeated verification condition)"],"plain_english_summary":"**What this instrument does (mechanically)**\n\n- It lists the specific documents that must be submitted with an application to the Secretary of the Department for a “kind” of medical device to be included in the Australian Register of Therapeutic Goods (see definition of “application” and sections 5, 6, 7 and 6A). In short: it converts the statutory power in s.41FDB of the Therapeutic Goods Act 1989 into a detailed checklist of acceptable evidence.\n- The requirement is class‑specific. Separate rules apply for: non‑IVD medical devices (Class I, IIa, IIb, III) (section 5 and Schedule 1); IVDs (Class 1–4 and in‑house Class 4) (section 6 and Schedule 2); system/procedure packs and certain special‑purpose devices (section 7 and Schedule 3); and devices that are intended for export only (section 6A and Schedule 2A).\n- For each class the Determination identifies two broad categories of supporting material a manufacturer must provide where applicable: (a) evidence about the manufacturer’s quality management system (e.g. ISO 13485 certificates, MDSAP certificates, notified‑body quality management certificates, or an Australian conformity assessment certificate issued under the Act) and (b) evidence of product‑level conformity assessment (e.g. design‑examination, type‑examination, or specific national market approvals). The detailed mapping of which document is acceptable and which foreign authority may issue it is contained in the many tables in Schedules 1–3.\n- The instrument allows alternatives and higher‑level substitution: an applicant may provide the kind of information required for a higher risk class instead of the minimum for the class in question (section 8). It also sets a few exemptions where no information is prescribed (section 9).\n- Format rules: any document must be legible and either in English or accompanied by a certified translation (section 10).\n\n**Who this affects**\n\n- Manufacturers who apply to have a kind of medical device included in the Australian Register must provide these documents. That includes commercial manufacturers and (in certain limited cases) in‑house providers for Class 4 in‑house IVDs (Schedule 2 Part 4).\n- Sponsors / applicants who lodge the application with the TGA are affected because they must assemble and attach the listed documents.\n- Third‑party conformity assessors and regulators named in the schedules (TGA, notified bodies under EU Directives/Regulations, UK approved bodies, US FDA approvals, Health Canada, Japan PMDA/MHLW, Singapore HSA, MDSAP auditors, ISO/IAF bodies, etc.) are referenced because certificates or approvals issued by them are listed as acceptable evidence.\n\n**Why it matters (practical effects and implementation mechanics)**\n\n- It defines the *routes* by which a manufacturer can show compliance for registration purposes. A firm can rely on an Australian conformity certificate or on a range of foreign approvals/certificates (for example MDSAP, EU CE documentation, US 510(k)/PMA outcomes, Health Canada licences, Japanese PMD approvals, Singapore register entries) as listed in the schedules.\n- Costs and behaviour: the Determination changes the set of documents that manufacturers must obtain before seeking Register inclusion. For higher‑risk classes (Class IIb, III; IVD Classes 3–4) the paperwork is more extensive (quality system certificate + product assessment documents; for Class III, clinical evaluation report and instructions for use are required if no TGA conformity certificate is provided — section 5(7)(c)). Those requirements affect firms’ upfront compliance costs (audit fees, notified‑body fees, clinical data generation, translations) and influence which markets/approvals firms pursue first.\n- Incentives and substitution effects: because the instrument accepts a broad list of foreign approvals, manufacturers may substitute one conformity pathway for another (e.g. obtain an EU CE or US FDA clearance instead of an Australian conformity certificate) and then use that documentation in a TGA application. That reduces duplication of regulatory effort but increases reliance on foreign regulators’ assessment standards.\n- Implementation and administrative discretion: the TGA is the authority that recognises or issues many of the listed documents (Schedules 1–3). Where a document must be “issued or recognised by the regulatory authority in column 2” of the schedules, the TGA has to interpret and apply those cross‑references when processing applications. That creates administrative work (and some discretion) in verifying foreign certificates and dealing with date‑limited transitional entries.\n- Transitional/temporal complexity: several schedule entries are time‑limited (for example, acceptance of certain EU declarations or ISO 13485 certs only before specified dates such as 26 May 2022, 26 May 2026/2027, 1 Jan 2028/2029/2030). Manufacturers and assessors must track those cut‑off dates when deciding which evidence to rely on.\n\n**Key statutory hooks and concrete provisions to note**\n\n- Section 5: lists the kinds of information for medical devices other than IVDs by class. Note Class III requires extra documents if no TGA conformity certificate is supplied (clinical evaluation report and instructions for use) (s.5(7)(c)).\n- Section 6: parallel rules for IVDs, including specific references to EU IVD Regulation compliance evidence in some table items (s.6(1)–(6)).\n- Section 6A: sets the information required for devices intended for export only (s.6A(1)).\n- Section 7 and Schedule 3: system and procedure packs have their own bespoke rules, and additional requirements if the pack is supplied sterile (s.7(2)).\n- Section 8: allows submission of higher‑class information as an alternative (applicants may provide more stringent evidence than the minimum) — this is a deliberate accommodation of different conformity assessment routes.\n- Section 9: lists device categories for which no accompanying information is prescribed (notably most in‑house IVDs other than Class 4 in‑house IVDs) (s.9).\n- Section 10: requires legibility and English or certified translation (s.10).\n\n**Trade‑offs, risks and implementation frictions (concrete mechanics)**\n\n- Benefit: acceptance of many foreign conformity documents reduces duplicate audits and can speed market entry for manufacturers who already hold foreign approvals.\n- Cost/risks: it places reliance on the integrity and continued availability of foreign conformity routes (notified bodies, CE system, UK approved bodies, etc.). If those foreign systems change (for example notified bodies leaving the EU/UK system, dates for EU IVD transition), applicants and the TGA must adapt; the instrument already embeds several date‑limited clauses that reflect that risk.\n- Concentrated benefits: larger manufacturers with resource to obtain multiple international approvals (EU, US, Canada, Japan, MDSAP audits) gain flexibility; smaller manufacturers may face higher marginal costs if they must secure particular certificates to meet the lists in the schedules.\n- Compliance burden and opportunity cost: the Determination is procedural — it lowers the TGA’s need to re‑audit where recognised foreign evidence exists, but it shifts the compliance burden (costs, time) onto manufacturers who must secure and present the listed documents before inclusion applications.\n- Administrative discretion and verification load on TGA: the TGA must verify that submitted documents are issued or recognised by the listed foreign authorities and that they relate to the device kind applied for (see repeated “must relate to the kind of device” language in ss.5–7). That creates operational verification tasks and potential for queries between applicant and regulator.\n\n**Practical checklist for an applicant (takeaways)**\n\n- Identify the device class under the Regulations and whether it’s an IVD, in‑house IVD, system/procedure pack, special‑purpose device, or export‑only (see ss.5–7 and Schedules 1–3).\n- Use the schedule row for your device class to see which certificates or declarations are acceptable and which issuing authorities are recognised.\n- If relying on non‑English documents, include certified translations (s.10).\n- For Class III devices, if you don’t have a TGA conformity certificate, be prepared to attach a clinical evaluation report and instructions for use with the application (s.5(7)(c)).\n\n(End of summary.)"},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-medical-devices-information-that-must-accompany-application-for-inclusion-determin","history":"/api/acts/therapeutic-goods-medical-devices-information-that-must-accompany-application-for-inclusion-determin/history","analysis":"/api/acts/therapeutic-goods-medical-devices-information-that-must-accompany-application-for-inclusion-determin/analysis","conflicts":"/api/acts/therapeutic-goods-medical-devices-information-that-must-accompany-application-for-inclusion-determin/conflicts","importantCases":"/api/acts/therapeutic-goods-medical-devices-information-that-must-accompany-application-for-inclusion-determin/important-cases","documents":"/api/acts/therapeutic-goods-medical-devices-information-that-must-accompany-application-for-inclusion-determin/documents"}}