TGA Publishes updated MDIR Guide
Last week, the Australian regulator, the Therapeutic Goods Administration (TGA) published an updated guidance for Australian Sponsors and Manufacturers for the reporting of adverse events in Australia (Medical device incident reporting (MDIR) guide).
The updated guidance provides further clarity around some specific sections that have generated questions in the past. Specifically, it clearly defines the TGA’s expectations around similar events reported, which has been one area misunderstood by sponsors and manufacturers in the past. It goes further, to define that the data that is to be provided to the TGA includes both local (Australian) and Worldwide data. Certainly, in respect to Brandwood CKC clients, we’ve seen some confusion around what data a manufacturer produces to what is expected by the local regulator.
This continued increase of post market scrutiny by regulators shows the need for both manufacturers and sponsors alike to ensure they’ve robust agreements in place. Such agreements provide confidence in the availability of not only the post market data required but also relevant information that can be requested at any stage a product is listed on the Australian Register of Therapeutic Goods (ARTG).
If you have any questions around adverse event reporting, recalls or any other post market activities, be sure to reach out directly for a no obligation with one of our team.
We offer deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)