The Medical Devices Vigilance Program (MDVP) – pilot aims to assist and support Australian medical device sponsors to comply with their post-market vigilance responsibilities under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002.
It complements our post-market surveillance of medical devices. This pilot includes post-market reviews of devices and manufacturer audits.
Information Session
An Information Session (webinar) will be held on Thursday 14 September 2023, 11:00am – 12:00pm AEST, for sponsors to learn more about the MDVP, its processes and what to expect in the pilot program.
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 and free for sponsors.
Sponsors who volunteer have the opportunity to work with us, at the Therapeutic Goods Administration (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 this pilot will shape the ongoing development of this important program and improve the safety of Australian patients using medical devices.
MDVP pilot process
Sponsors wishing to participate in the MDVP pilot can register for the Information Session or 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/or on-site inspection by the TGA, to support regulatory education and compliance.
Updates on the pilot will be provided on this MDVP webpage.
Contact us
If you have any questions or would like to participate, contact us at: MDVP@health.gov.au
More information
- Post market responsibilities for manufacturers and sponsors of medical devicesGuidanceStart here to learn the basics on the mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.