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November 16, 2025
Approximately 5 minutes
Post-Market Surveillance: Mandatory Adverse Event Reporting
Singapore Post-Market Surveillance: Mandatory Adverse Event Reporting to HSA
Post-market surveillance (PMS) and vigilance reporting in Singapore are mandatory for all medical devices and are governed by the Health Products Act and the Health Products (Medical Devices) Regulation 2010. The system, managed by the Health Sciences Authority (HSA), focuses on prompt and thorough reporting of Adverse Events (AEs).
Adverse Event (AE) Reporting Requirements
The local Registrant or Distributor is primarily responsible for submitting AE reports to the HSA. However, the manufacturer is responsible for ensuring all necessary data is available, as the reporting timeline starts as soon as any personnel (manufacturer or distributor) are notified of the event. HSA's guidance for AE reporting is found in GN-05-R2.1.
An event is considered a reportable Adverse Event if all three criteria are met:
- An Adverse Event has occurred.
- The medical device is demonstrably associated with the AE.
- The AE led to one of the following serious outcomes:
- Death of a patient, user, or other person.
- Serious deterioration in the state of health of a patient, user, or other person.
- A serious threat to public health.
- No death or serious injury, but the event, if it recurs, might lead to death or serious injury.
Note: HSA generally does not require reports for AEs occurring outside of Singapore unless the event's recurrence could lead to death or serious injury.
Mandatory Reporting Timelines
The urgency of reporting an AE to the HSA is dictated by the severity of the outcome, with all reports expected to be submitted immediately upon confirmation.
| Severity of Adverse Event | Mandatory Reporting Deadline |
|---|---|
| Serious Threat to Public Health (e.g., contamination, widespread failure) | Not later than 48 hours from confirmation |
| Led to Death or Serious Deterioration in Health | Not later than 10 days from confirmation |
| Potential Serious Deterioration upon Recurrence (No death/serious injury yet, but recurrence might) | Not later than 30 days from confirmation |
A final, comprehensive report for the event should typically be submitted within 30 days of the initial report, regardless of the initial submission timeline.
Field Safety Corrective Actions (FSCA)
If a manufacturer initiates a Field Safety Corrective Action (e.g., product recall, modification, or notice) anywhere in the world due to a medical device safety issue, they must notify the HSA about this action, even if the device has not experienced the reported AE in Singapore. This ensures the HSA can assess the risk to Singaporean users.
Effective PMS is critical for maintaining the device registration and the Dealer's License in Singapore.
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