The sponsor of a medical device that is:
- an implantable Class IIb device; or
- A Class III device; or
- an Active Implantable Medical Device (AIMD) (now Class III devices); or
- a Class 4 in vitro diagnostic (IVD) device.
Then the sponsor should submit three consecutive annual reports to TGA after the device is included in the ARTG as a post marketing obligation.
The submission of annual reports is part of the device lifecycle approach for the sponsor to demonstrate that:
- high risk devices that are new to the Australian market continue to meet the Essential Principles for safety and performance; and
- the manufacturer’s post-market surveillance system can identify any safety or performance issues or signals associated with the device as early as possible.
Due dates and reporting periods:
Annual reports should cover the period from 1 July to 30 June and are due on 1 October each year. The first report should be for a period of at least six months, but not longer than 18 months. If the information is limited to the time the device has been on the Australian market because it hasn’t been supplied elsewhere, this should be stated in the report.
Subsequent reports are to be provided by 1 October for a further 2 years.
Submission of annual report:
Annual reports must be provided in electronic form and can be emailed to medicaldevicesurveillance@health.gov.au marked for the attention of the Annual Report Coordinator.
Format of annual report:
You should include the following in your annual report:
- ARTG number.
- Product name(s).
- Model number(s).
- Number of devices supplied in Australia by product/model.
- Number of devices supplied worldwide (numbers should include devices that are the same but supplied under a different name in another jurisdiction) by product/model.
- Number of complaints in Australia by product/model.
- Number of complaints by product/model.
- Number of adverse events and incident rates in Australia (Rate = No. of events/No. Supplied x 100 = Rate %).
- Number of adverse events and incident rates world-wide.
- A list of all complaints and adverse events identifying the jurisdiction where the complaint or adverse event originated.
- Device Incident Report (DIR) number of those adverse events reported to us.
- Details of any regulatory/corrective action/notification by the manufacturer.
Reference:
https://www.tga.gov.au/resources/resource/guidance/annual-reports
