Australia

The TGA is in the process of establishing the Australian Unique Device Identification Database (AusUDID). The TGA is hosting a webinar to provide an update on the Australian UDI implementation and a presentation on learnings and the real-world benefits of the UDI adoption in the US healthcare system. The webinar is held on 21 November from 11:30am to 12:30pm (AEDT).…

The TGA is commencing a 12-month pilot of the new Medical Devices Vigilance Program. Sponsors who have medical devices included in the Australian Register of Therapeutic Goods can volunteer for the pilot. The pilot is designed to support medical device sponsors comply with regulation and give the public confidence that sponsors are meeting their responsibilities. More information on this program…

Following the phase out of ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, the TGA have published a guidance that helps sponsors to transition to using another form of manufacturer evidence to ensure ongoing regulatory compliance. The new guidance can be found here.