Medical Devices Vigilance Program - Pilot

The Medical Devices Vigilance Program (MDVP) Pilot aims to assist and support Australian medical device sponsors to comply with their post-market surveillance responsibilities under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002.

It complements our post-market surveillance of medical devices, including post-market reviews, adverse event monitoring, and auditing manufacturers.

Information Session

An Information Session (webinar) was held on 14 September 2023, for sponsors to learn more about the MDVP Pilot, its processes and what to expect in the program.

See more information about the information session and the webinar slides.

Participating in the MDVP pilot

All Australian medical device sponsors who have an entry in the Australian Register of Therapeutic Goods (ARTG) are eligible to participate in the MDVP Pilot.

Participation in the MDVP Pilot is voluntary.

Sponsors who volunteer have the opportunity to work with us, at the TGA, and learn more about their post-market regulatory requirements. Participants will improve their understanding of whether their processes or procedures are sufficient to ensure compliance with the legislative requirements.

The information gathered through the MDVP Pilot will shape the ongoing development of this important program and improve the safety of Australian patients using medical devices.

MDVP pilot process

Sponsors who were unable to attend the Information Session, yet would like to participate in the MDVP Pilot, can contact us at MDVP@health.gov.au.

The MDVP Pilot will run for 12 months.

Participating sponsors will be invited to complete and submit the Sponsor Vigilance Self-Assessment Tool (SAT) to us. The SAT is a questionnaire containing links to the regulations. It is intended to help sponsors to better understand their post-market regulatory obligations. The tool will help us select sponsors for a desktop audit and on-site inspection, as well as support regulatory education and compliance. 

Updates on the Pilot will be provided on this MDVP webpage.

Information collection by the TGA

We collect information throughout the SAT, DTA and inspection stages.

We only use this information for post-market surveillance. It is stored in secure databases for legislated timeframes. Our records management system can retrieve relevant documents and trace the measures taken to investigate safety concerns or non-compliance observed across the MDVP Pilot processes.

Third parties will not receive your information.

See our privacy statement.

Contact us

If you have any questions or would like to participate, contact us at: MDVP@health.gov.au