Quote from VigiServe Admin on November 26, 2020, 11:04 AM

Annual reporting aims to ensure that:

• high risk devices that are new to the Australian market continue to meet the Essential Principles for safety and performance; and

• the post-market surveillance system is able to identify any safety or performance issues or signals associated with the device as early as possible.

If you are a sponsor of a medical device that is:

• an implantable Class IIb device; or

• a Class III device; or

• an active implantable medical device (AIMD); or

• a Class 4 in vitro diagnostic (IVD) device

then one of your automatic post-market obligations is to provide three consecutive annual reports to us after your device is included in the Australian Register of Therapeutic Goods (ARTG).

Timing of annual reports

Annual reports should cover the period from 1 July to 30 June and are due on 1 October each year. Your first report should be for a period of at least six months, but not longer than 18 months.

What should an annual report include?

Your annual report should contain the following information:

• 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.

Template - Refer Attachment