ANSWERED ON THIS PAGE:
- When are vigilance reports required?
- What is the vigilance reporting process in Singapore?
- How can we comply with vigilance requirements in Singapore?
Singapore's Health Sciences Authority (HSA) requires medical device manufacturers to comply with a vigilance system for post-market monitoring and adverse event reporting. Companies that fail to accurately report adverse incidents could face severe financial penalties or, in extreme cases, criminal charges. Singapore authorities will not accept ignorance as an excuse for not implementing a vigilance system. An experienced regulatory partner can help you comply with the HSA's post-market requirements.
When are vigilance reports required in Singapore?
If you are a manufacturer, you or your Singapore Registrant should report adverse incidents to the HSA. You must report an adverse event in Singapore if a medical device has contributed to one of these outcomes:
- serious threat to public health
- death of a patient, user or other person
- serious deterioration in state of health of patient, user or other person
- no death or serious injury occurred, but the event might lead to death or serious injury if it recurs
Field safety corrective actions (FSCAs), such as recalls, must be reported to the HSA at least 24 hours before initiating the FSCA. A preliminary report with thorough information about the FSCA should also be submitted within 24 hours. A recall notice detailing the hazards associated with the medical device and corrective actions taken should be distributed to consumers. A final recall report must be submitted to the HSA within 21 days.
Singapore medical device vigilance reporting process
Below are the basic steps you should follow in reporting an adverse event in Singapore:
- Inform your Singapore Registrant and the HSA that a reportable adverse event has occurred.
- Investigate the cause of the adverse event and report all findings to the HSA.
- If necessary, inform HSA of Field Safety Corrective Action plan.
- Distribute a recall notice to consumers in Singapore.
- Submit final recall report to the HSA.
- Add all reports, along with any correspondence with the HSA, to your Quality Management System records.
Need help with vigilance reporting in Singapore?
Emergo has excellent relationships with HSA officials and are very familiar with handling vigilance issues and incident reporting in Singapore and around the world. Working with Emergo offers you the following benefits:
- If we act as your Singapore Registrant, we can submit adverse event reports and recall information to the HSA on your behalf.
- Our in-depth knowledge of HSA medical device regulations ensures your vigilance procedures will always be up-to-date.
- Our experienced consultants can help you determine when incidents are reportable and ensure that reports required by the HSA are completed on time.
- We have experience assisting hundreds of manufacturers with post-market surveillance, Singapore HSA registration, and other regulatory consulting services.
We can help you comply with post-market surveillance and vigilance reporting requirements in Singapore.
How can we learn more about vigilance reporting requirements?
The Health Products (Medical Devices) Regulation, GN-04-R2, GN-05-R2, and GN-10-R2 offer valuable information on terminology, timelines, and other vigilance reporting requirements in Singapore.
Do we have to report events that happened outside of Singapore to the HSA?
Adverse events that occur outside Singapore do not require reporting unless the registration or license conditions require it, or a notice requesting adverse event information has been issued by the HSA.
When should we submit an initial event report to the HSA?
This varies based on the severity of the event. Some reports should be submitted within hours, while others allow days or even weeks. Emergo can assist you in evaluating how and went to submit an initial event report to the HSA.