Regulatory Updates for Australia as a result of the RegTech Forum
On June 22 we attended “Sponsor Information and Training Day” in Canberra organized by the “Regulatory and Technical Consultative Forum for medical devices” (RegTech Forum). RegTech Forum facilitates consultation between TGA and the medical device industry. TGA officials made presentations on current issues and the event enabled discussion on regulatory and technical topics significant to the medical device industry.
As manufacturers likely appreciate, in the capacity of Australian Sponsor, we submits information required under Section 41FD of the Therapeutic Goods Act, “Matters to be certified”. This information is related to device classification, compliance with essential principles, and more. We appreciate that TGA actively monitors and reviews Medical Device Applications and ARTG listing numbers. While Class I self-certified device applications are subject to random reviews, other device classifications may be subject to flagged and targeted reviews. It is notable that TGA has collected AUD $3M in civil penalties for medical devices which did not possess an ARTG listing as required.
Other key topics included:
- TGA expects medical device Clinical Evaluation Reports to be reviewed and signed by clinical experts.
- All IVDs will require an ARTG listing or an active medical device application before June 30, 2014. Also, all IVDs will require a Clinical Evidence Report.
- As we reported earlier this year, TGA strongly encourages on-line adverse event reporting. At this time, only Initial Reports can be submitted electronically. However, electronic submission of reports will become mandatory when developments enable online submissions of Follow-up and Final Reports.
- Visitors to the publically accessible ARTG listing web site will find that modifications have recently been implemented. These modifications aim to make the site more consumer-friendly and informative. As reported previously, TGA is in the process of implementing the ARTG listing requirements so that each listing will reference explicit model numbers.
- The suggestion to include the ARTG listing number on device labelling has been withdrawn based on industry feedback.
TGA's fees have not yet been published even though the new fiscal year commences on July 1, 2012. We will continue to monitor TGA’s activities and keep you informed of future developments.