Post market surveillance is required for all events occurring in Singapore in accordance with the Health Products Act and the Health Products (Medical Devices) Regulation 2010. The HSA requires medical device manufacturers to be diligent about reporting Adverse Events (AEs) with further guidance found here. While the distributors are primarily responsible for reporting the AE, it’s important for manufacturers to remember that the clock begins ticking as soon as any personnel are notified of the AE and a final report should be reported within 30 days of the initial report. It’s also important to note that the HSA doesn’t require you to submit reports for AEs occurring outside of Singapore unless possible death or serious injury could happen if the AE were to occur.
Reportable Adverse Events
The following three criteria must be met to be considered a reportable AE:
An AE has occurred,
The medical device is associated with the AE,
The AE led to one of the following outcomes:
A serious threat to public health,
Death of a patient, user or other person,
Serious deterioration in state of health, user or other person,
No death or serious injury but the event might lead to death or serious injury of a patient, user or other person if the event recurs.
All AEs should be reported immediately and
not later than 48 hours for events that represent a serious threat to public health,
not later than 10 days for events that led to death or serious deterioration in state of health,
not later than 30 days for events where a recurrence of which might lead to death or serious deterioration in state of health.
Adverse Event Reporting Guidance can be found in GN-05-R2.1
Contact Asia Actual with questions regarding Singapore Post Market Surveillance. Our local, bi-lingual regulatory experts are well positioned to assist.