Medical devices vigilance program pilot

The TGA is commencing a new Medical Devices Vigilance Program (MDVP). The MDVP will begin as a 12-month pilot. The pilot is designed to support medical device sponsors comply with regulation and give the public confidence that sponsors are meeting their responsibilities.

Sponsors who have medical devices included in the Australian Register of Therapeutic Goods (ARTG) are able to volunteer for the pilot.

Objectives of the MDVP pilot

Sponsors need to have systems in place to monitor the performance of the devices they supply, receive, update and maintain information about their devices and report details of adverse event and performance issues to us. These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002.

The MDVP pilot aims to identify areas that may require improvement, to ensure there is appropriate monitoring and communications to support the ongoing safety of medical devices available to the Australian public.

How to get involved

To volunteer for the MDVP pilot and find out more about it, see our Medical Devices Vigilance Program page.