Australia: Proposed Amendments to Medical Device Conformity Assessment Procedures

Australia’s Department of Health has proposed updates to medical device conformity assessment procedures to align with global standards, including the EU MDR and MDSAP. Public consultation is open until 31 March 2026.

The amendments aim to simplify regulatory requirements, strengthen design controls, and enhance post-market monitoring. Key updates include improved Post-Market Surveillance (PMS) requirements, aligning with EU practices such as PMS Reports (PMSR) for Class I devices and Periodic Safety Update Reports (PSUR) for higher-risk devices.

Adverse event reporting timelines remain critical, requiring notification within 48 hours for serious threats, 10 days for severe incidents, and 30 days for others. The proposals also emphasize robust clinical evaluation and post-market clinical follow-up, especially for high-risk and implantable devices.

These changes aim to improve regulatory consistency, product safety, and global compliance for medical device manufacturers in Australia.

Region: Australia
Source: https://www.tga.gov.au/products/regulations-all-products/tga-reforms/medical-devices-reforms/reviewing-conformity-assessment-procedures