For those Sponsors in Australia that included an active implant (AIMD), Class III, Implantable Class IIb or Class 4 IVD product onto the register in the last 3 years, don’t forget to submit your annual report by October 1. Failure to do so can lead to suspension or cancellation of your product from the ARTG.
What to include in the annual report?
For each device subject to reporting a report should include all of the following information.
- ARTG no
- Product name
- Model no(s)
- Number supplied in Australia
- Number supplied world wide (Numbers should include devices that are the same but supplied under a different name in another jurisdiction)
- Number of complaints in Australia
- Number of complaints world wide
- 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 the more common complaints and all of the adverse events
- Device Incident Report (DIR) number of those adverse events reported to the TGA
- Regulatory/corrective action/notification by manufacturer
Who must report?
Sponsors of an Active Implant (AIMD), Class III, implantable Class IIb medical device or Class 4 IVD included on the ARTG in the last three years (1/1/14 – 31/12/16) are required to supply the TGA with an annual postmarket report for all devices supplied or potentially supplied under your ARTG entries.
Reporting is a Standard Condition of Inclusion of all high risk devices listed above. TGA has recently written these conditions directly into regulation in preparation for stricter enforcement. See our related blog here
For guidance on what to submit please review and follow the information in the Australian Regulatory Guidance for Medical Devices https://www.tga.gov.au/sites/default/files/devices-argmd-p3.pdf and information supplied to you in a letter from the TGA requesting annual report data.
Need help with TGA regulatory compliance? We are experienced in all aspects of TGA regulatory oversight – including premarket filings and postmarket compliance. Contact our Sydney office for a free, no obligation discussion. Call us on +61 2 9906 2984 or email email@example.com.