The Therapeutic Goods Administration (TGA) of Australia implemented the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Amendment Determination (No.2) 2024 on September 18, 2024.
This amendment modifieds the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Determination 2018 (“the Principal Determination”), expanding the reference countries (US FDA) for medical device conformity certificates submitted during ARTG (Australian Register of Therapeutic Goods) inclusion application.
The purpose of this expansion is to reduce the regulatory burden on manufacturers and importers.
The details of the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Amendment Determination (No.2) 2024 are as follows:
1) Before subsection 5(7)
The amendment revises subsection 5(7) of the Principal Determination by adding the title “Class III medical device”
2) Paragraph 5(7)(a)
The amendment modifies paragraph 5(7)(a) of the Principal Determination to omit the reference to Division 1 of Part 4 of Schedule 1.
3) Part 2 of Schedule 1 (cell at table item 8, column 4)
When submitting conformity assessment documents from the US FDA for the registration of Class IIa medical de vices to the ARTG, manufacturers are now required to submit only the MDSAP (Medical Device Single Audit Program) certificate issued by a recognized auditing organization.
However, applications for inclusion of medical device that are not exempt from the requirements in US FDC Act 510(k) are still required conformity assessment documents supporting the substantial equivalence determination or De Novo approval based on filings made under the US FDC Act.
4) Part 4 of Schedule 1 (cell at table item 11, column 4)
This division has been amended to expand the range of conformity assessment documents that applicants can submit in support of their applications to the TGA. If the US FDA conformity assessment documents specify the requirements for Class III medical devices, the applicants must include the following documents.
- The MDSAP certificate related to the manufacturer’s quality management system (QMS) issued by a recognized auditing organization, and either of the following:
(a) An approval order for premarket approval application under section 515 of the US FDC Act; or
(b) A determination of substantial equivalence based on a submission made under section 510(k) of the US FDC Act.
Please refer to the attached document below.
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