Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
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Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:
(a) conformity assessment certificate;
(b) conformity assessment document;
(c) conformity assessment procedures;
(d) included in the Register;
(e) kind, in relation to a medical device;
(f) medical device;
(g) system or procedure pack.
In this instrument:
Act means the Therapeutic Goods Act 1989.
application means an application to the Secretary for a kind of medical device to be included in the Register under section 41FC of the Act.
applied Directive 90/385 has the meaning given to “Directive 90/385” in regulation 2(1) of the UK Regulations, and a reference to an Annex in applied Directive 90/385 is to be construed in accordance with regulation 2(1A) of the UK Regulations.
applied Directive 93/42 has the meaning given to “Directive 93/42” in regulation 2(1) of the UK Regulations, and a reference to an Annex in applied Directive 93/42 is to be construed in accordance with regulation 2(1A) of the UK Regulations.
applied Directive 98/79 has the meaning given to “Directive 98/79” in regulation 2(1) of the UK Regulations, and a reference to an Annex in applied Directive 98/79 is to be construed in accordance with regulation 2(1A) of the UK Regulations.
Canadian medical devices regulations means the Medical Devices Regulations (SOR/98-282) made under the Food and Drugs Act of Canada, as in force immediately before the commencement of this instrument.
certified translation means a translation that contains a statement, dated and signed by a person, to the effect that the translation is a true and complete translation of the accompanying document.
Class 1 IVD medical device has the same meaning as in the Regulations.
Class 2 IVD medical device has the same meaning as in the Regulations.
Class 3 IVD medical device has the same meaning as in the Regulations.
Class 4 IVD medical device has the same meaning as in the Regulations.
Class 4 in-house IVD medical device has the same meaning as in the Regulations.
Class I medical device has the same meaning as in the Regulations.
Class IIa medical device has the same meaning as in the Regulations.
Class IIb medical device has the same meaning as in the Regulations.
Class III medical device has the same meaning as in the Regulations.
clinical evaluation report means a report prepared by a manufacturer detailing the assessment and analysis of clinical data to verify the safety and performance of a medical device when used as intended by the manufacturer.
Council Directive 90/385/EEC means Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) of the Council of the European Communities, as in force immediately before the commencement of this instrument.
Council Directive 93/42/EEC means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices of the Council of the European Communities, as in force immediately before the commencement of this instrument.
Directive 98/79/EC means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, as in force immediately before the commencement of this instrument.
EU IVD regulation means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force on 1 December 2024.
EU medical devices regulation means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force immediately before the commencement of this instrument.
Section 4 - Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 - Definitions | Zoe
generic device group has the same meaning as in the EU IVD regulation.
IAF accredited conformity assessment body means a body that is accredited to undertake certification for compliance with ISO 13485 by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA.
implantable medical device has the same meaning as in the Regulations.
in-house IVD medical device has the same meaning as in the Regulations.
instructions for use has the same meaning as in the Regulations.
ISO 13485 means International Standard ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, issued by the International Organization for Standardization in March 2016, as in force or existing immediately before the commencement of this instrument.
IVD companion diagnostic has the same meaning as in the Regulations.
IVD medical device, or in vitro diagnostic medical device, has the same meaning as in the Regulations.
IVD medical device for self-testing has the same meaning as in the Regulations.
Japanese PMD Act means The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices of Japan, as in force immediately before the commencement of this instrument.
manufacturing licence has the same meaning as in the Regulations.
MDSAP certificate means a certification document issued by a recognised or authorised auditing organisation, following the completion of an audit of a manufacturer’s quality management system.
measuring function has the same meaning as in the Regulations.
medical device used for a special purpose has the same meaning as in the Regulations.
NATA has the same meaning as in the Regulations.
notified body means a body that has been designated by a member state of the European Union, and notified to the European Commission, to assess the conformity of medical devices, including in vitro diagnostic medical devices and active implantable medical devices.
point of care testing has the same meaning as in the Regulations.
quality management system certificate means a certificate that is issued following an assessment of a manufacturer’s quality management system, but does not include a MDSAP certificate.
recognised or authorised auditing organisation means an organisation that is recognised or authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council in relation to that program, comprising Australia’s Therapeutic Goods Administration, the United States Food and Drug Administration, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency.
Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
relevant implantable medical device means an implantable medical device other than a medical device:
(a) mentioned in paragraphs 13A.1(1)(b) or (ba) of Schedule 1 to the Regulations; or
(b) to which subclause 13A.1(2) of Schedule 1 to the Regulations applies.
Note: Medical devices mentioned in paragraph 13A.1(1)(b) of Schedule 1 to the Regulations include, for example, sutures, staples, dental fillings and dental braces. The medical devices mentioned in paragraph 13A.1(1)(ba) of Schedule 1 to the Regulations are medical devices that are intended by the manufacturer to be for export only.
Singapore Health Products Act means the Health Products Act 2007 of Singapore as in force on 1 July 2022.
Singapore Register of Health Products means the Register of Health Products kept and maintained by the Health Sciences Authority of Singapore under section 34 of the Singapore Health Products Act.
Therapeutic Goods Administration means that part of the Department known as the Therapeutic Goods Administration.
UK approved body has the meaning given to “approved body” in regulation A45 of the UK Regulations.
UK Regulations means the Medical Devices Regulations 2002 (SI 2002/618), as in force in England, Wales and Scotland on 1 December 2025.
Note: The UK Regulations could in 2025 be viewed on the UK legislation website (www.legislation.gov.uk).
US FDC Act means the Federal Food, Drug, and Cosmetic Act of the United States, as in force immediately before the commencement of this instrument.