Think Ahead, Be Prepared – TGA Post-market Review

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Aug 11, 2022
2 min read

Medical Device (MD) and in vitro diagnostic device (IVD) sponsors and manufacturers will likely face post-market review at some point. Sponsors and manufacturers should ensure post-market review processes and surrounding obligations are understood, and handled effectively and efficiently.

Recently, the Therapeutic Goods Administration (TGA) cancelled the registration of four COVID-19 rapid antigen tests (RATs). Despite surrounding media, the TGA stressed these RATs were not cancelled for failure to detect the Omicron variant.

In a recent media release, the TGA clarified:

“One product was cancelled…because the sponsor didn't provide sufficient data to demonstrate the sensitivity of the test for COVID-19 detection with the required guidelines. The remaining three were cancelled by the supplier, who can stop supplying…for a range of reasons and are not required to explain their rationale”.

Significantly, the TGA’s recent reviews of RATs serves to remind sponsors and manufacturers of post-market review structures, approval conditions, and associated obligations.

TGA Post-market Review processes for MD and IVDs

Prudent organisations and individuals should know how they will approach the possibility of post-market review even before product registration.

The TGA may initiate a post-market review for many reasons. As highlighted by the TGA, reviews can be sparked by various events, including adverse reporting, identification of safety or efficacy issues, and “unresolved or repeated recalls”.

Signalling review commencement, sponsors and manufacturers will receive written notice and a request for further information. The TGA detail:

“This letter will contain a request for specific information we require…to conduct the review”.

Following TGA assessment of responses and provided information, the regulator will work with organisations to “implement appropriate corrective actions” if necessary.

The TGA has made a summary of post-market review processes available here.

The process appears seamless, but don’t be fooled. Post-market review can be time-consuming, labour-intensive, and costly if mismanaged.

Additionally, continuing product registration hinges not only on compliance, but also commercial factors. In certain circumstances, it might even make sense to seek registration cancellation.

Organisations should be aware of the compliance-related consequences, and commercial effects of post-market review.

We are experts in managing post-market reviews. Komply can help you respond to TGA requests for information, manage associated issues, and help avoid unnecessary cancellation.

Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters in human and veterinary applications.

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