ANSWERED ON THIS PAGE:
- What is the medical device vigilance reporting process in Australia?
- What does the TGA consider an adverse event?
- What is the role of the Australian sponsor in Australian vigilance reporting?
The importance of medical device vigilance reporting
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 and recalls to the 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 and recalls are reported correctly. Companies that fail to accurately report vigilance could face severe financial penalties or criminal sentences. Regulatory professionals must proactively reach out to their sponsors if vigilance reporting is necessary.
Adverse event reporting
An adverse event is an occurrence that involves a death, serious injury or serious deterioration, including a life-threatening illness or injury, permanent impairment to a body function, permanent damage to a body structure or a condition necessitating medical or surgical intervention to prevent permanent impairment to a body function or permanent damage to a body structure. This includes “near adverse events,” which are occurrences that might have led or could lead to death or serious injury if they were to recur. The Australian sponsor must report adverse events occurring in Australia to the TGA using the Medical Device Incident Reporting (MDIR) system.
Recall and non-recall actions
You must also notify your sponsor if you are contemplating a recall to correct or remove a product from the Australian market. It is also important to note that the TGA requires notification of non-recall actions before any action is taken. Your Australian sponsor will present recall information and a recall letter to the Australian recall coordinators, who will then approve the action.
Below are the basic steps you should follow in reporting recall/non-recall actions in Australia:
- Inform your Australian sponsor if a recall or non-recall action is necessary. Your sponsor will submit the required information — including your Health Hazard Evaluation, distribution list and customer letter — to the TGA on your behalf.
- Once the TGA approves, the action can proceed with notification of customers, etc.
- Complete TGA-required follow-up recall reports at two weeks and six weeks, and the closure report at three months (if classified as a recall action).
- Add all reports to ISO 13485 or other quality system records.
Why choose Emergo to assist with Australian vigilance reporting?
Emergo represents more than 400 medical device and in vitro diagnostic (IVD) companies as an Australian sponsor. Our team frequently helps 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 TGA and their Australian Recall Coordinators on your behalf.
- Our in-depth knowledge of the Australian medical device market can help you keep your vigilance procedures up to date.
- Our experienced consultants can help determine when incidents are reportable and ensure that final incident reports are completed on time.
- We can help plan your recall strategy and execute customer communications to help fulfill the TGA’s high expectations for response reconciliation.
- We have experience assisting hundreds of manufacturers with post-market surveillance, Australian Register of Therapeutic Goods registration and other regulatory consulting services.