TGA will no longer send “friendly reminders” for Annual Reports.
In a communication on May 15th, TGA announced they will no longer be providing courtesy formal correspondence requesting annual reports from Australian Sponsors, and failing to provide annual reports may result in regulatory action.
In this article, we also take a look at the requirements Medical Device manufacturers have to abide to with in regards to their annual reports.
TGA has historically provided correspondence to Sponsors to remind Device Manufacturers that their Annual Reports are due. However, TGA will no longer be providing these reminders and instead, “failure to provide the information by the due date will result in regulatory action.”
It is unclear, or better yet to be decided, what regulatory action may be undertaken by TGA, but we estimate this will be a function of the regulatory compliance and adverse event history of the Device Manufacturer.
To read more about this notice follow this link to the TGA website:
Who needs to supply Annual Report to TGA?
As a matter of automatic condition for inclusion with the Australian Register of Therapeutic Goods (ARTG) sponsors of medical devices for:
• Class IIb (implantable),
• Class III,
• Active Implantable Medical Devices, or
• Class 4 IVDs
Are required to submit annual reports to the TGA for the first 3 years of inclusion in the ARTG.
When is the deadline?
These annual reports are due on October 1st of each year.
What are the contents of these submissions?
The reports must include all complaints received by the manufacturer relating to problems with the use of the device that have been received over the year.
This should include complaints received for product sold under different name, and in any other country where the device is sold. Notoriously the report should include the following amongst other requirements:
• Number supplied in Australia and world wide (Numbers should include devices that are the same but supplied under a different name in another jurisdiction)
• Number of complaints in Australia and 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
To learn more about Annual Reports refer to the Medical Device Guidance:
Manufacturers should be well versed and ensure these annual report requirements are met on time in order to avoid regulatory action, including cancellation from the register.
At Brandwood Biomedical, we understand that post market surveillance and monitoring is evolving, and the shifting regulations globally require systems, checks and balances to ensure ongoing compliance. We would love to speak with you about our comprehensive sponsorship options which include assistance and reminders to complete annual reports, so that our clients are not surprised with due dates.
Our sponsorship services in Australia cover these types of requirement, and ensure you remain in compliance, and these services are constantly including more jurisdictions.
Please reach out to schedule a time to speak.
Looking to fly south for warmer weather? We have the skills in all aspects of Australian regulatory and reimbursement requirements and can assist you to prepare and file regulatory submissions to TGA. We can also hold Australian licenses on behalf of international manufacturers. Talk to us today about how to leverage international reviews to achieve TGA registration. Contact us for a free, no obligation discussion. Email [email protected] or call us: 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)