The Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002 state that medical device manufacturers and Sponsors are legally required to report adverse events to the Therapeutic Goods Association (TGA).
The Australian Regulatory Guidelines for Medical Devices (ARGMD) and Uniform Recall Procedure for Therapeutic Goods (URPTG) offer manufacturers valuable information on terminology, timelines and other vigilance reporting requirements in Australia.
Your Australian Sponsor – a regulatory liaison between you and the TGA if you are located outside Australia - works to ensure that any adverse events or recalls are reported correctly. Companies that fail to accurately report incidents to could face severe financial penalties or criminal sentences. Regulatory professionals must be proactive in reaching out to their Australian Sponsor if vigilance reporting is necessary.
When Are Adverse Events Reportable?
Adverse events occurring in Australia must be reported to the TGA if a device malfunctions, deteriorates in performance, has inadequate instructions or improper labeling that result in death or serious injury, or may lead to death or serious deterioration in state of health if it were to recur. The adverse event must be submitted using the Medical Device Incident Reporting (MDIR) System.
Your Sponsor must also be notified if you are contemplating a recall to correct or remove a product from the Australian market. Your sponsor will present recall information to the Australian Recall Coordinators who will then approve the action and recall letter prior to any action taken in Australia.
Australia Medical Device Vigilance Reporting Process
Shown below are the basic steps you should follow in reporting an adverse event in Australia:
- Inform your Australian Sponsor that a reportable adverse event has occurred. Your Sponsor will then submit the adverse event to the TGA on your behalf.
- Inform your Australian Sponsor if a recall is necessary. Your Sponsor will submit the recall to the TGA on your behalf.
- Complete follow-up recall reports required by the TGA at two weeks, six weeks and the closure report at three months.
- Add all reports to ISO 13485 or other quality system records.
Why choose Emergo to assist with Australian vigilance reporting?
Emergo represents more than 150 medical device and IVD companies as an Australian Sponsor. Our team is frequently involved in helping companies with incident reporting and recalls for Australia.
- If we act as your Australian Sponsor, we can submit adverse event reports and recall information to the Therapeutic Goods Association and their Australian Recall Coordinators on your behalf.
- Our in-depth knowledge of the Australian medical device market ensures that your vigilance procedures will always be up-to-date.
- Our experienced consultants can help determine when incidents are reportable and that ensure that final incident reports are completed on time.
- We have experience assisting hundreds of manufacturers with post market surveillance, ARTG registration and other regulatory consulting services.
Please contact us for more information on how we can assist you with medical device vigilance reporting for Australia.