Skip to main content

Adverse Event Reporting — What Must Be Reported

The obligation to report adverse events is set out in the HP(MD) Regulations 2010 and applies to all companies dealing in medical devices in Singapore — importers, manufacturers, wholesalers, and registrants.

What is a reportable adverse event?​

A reportable adverse event (AE) is any malfunction or deterioration in the characteristics or performance of a medical device, or any inadequacy in labelling or instructions for use, that has led to, or could lead to, the death or serious deterioration in the state of health of a patient, user, or other person.

This includes:

  • Serious injury or death caused by or suspected to be caused by the device;
  • Near-miss events where a malfunction occurred but serious harm was avoided by chance or timely intervention;
  • Device malfunctions that, if they recurred in a similar situation, could lead to serious harm;
  • Incorrect results from an IVD that led to, or could have led to, incorrect treatment causing serious harm.

Who must report​

All of the following must report AEs involving devices they deal in:

  • Importers of the device
  • Manufacturers (local manufacturers)
  • Wholesalers
  • Registrants (product registration holders)

Healthcare professionals and hospitals are encouraged to report AEs but are not subject to the same mandatory reporting obligations as dealers. HSA operates a separate voluntary reporting system for healthcare institutions.

What does not need to be reported​

Not every device-related complaint or incident is a reportable AE. Events that do not need to be reported include:

  • Deficiencies in device performance that are expected based on the device's known characteristics and do not cause patient harm;
  • Complaints resolved by device replacement where no patient harm occurred and no safety trend is indicated;
  • Events caused entirely by patient condition unrelated to device performance.

Official sources​