Singapore’s Health Sciences Authority (HSA) requires medical device manufacturers to comply with a vigilance system for post-market monitoring and adverse event reporting.
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.
Companies that fail to accurately report adverse incidents could face severe financial penalties or criminal sentences from the Singapore authorities. Ignorance is not an acceptable excuse for not implementing a vigilance system in Singapore.
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 the following 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 the it recurs
Field safety corrective actions, such as recalls, must be reported to the HSA at least 24 hours before the initiation of a FSCA. A preliminary report containing complete information on 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 also be distributed to consumers. A final recall report must be submitted to the HSA within 21 days.
Singapore Medical Device Vigilance Reporting Process
Shown 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?
We have established excellent relationships with HSA officials and are very familiar with handling vigilance issues and incident reporting in Singapore. 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 that 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.
Please contact us for more information on how we can assist you with medical device vigilance reporting in Singapore.