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Adverse Event Reporting — How to Report

The MDMIS portal​

Adverse event reports for medical devices are submitted to HSA through the Medical Device Manufacturers Information System (MDMIS). The portal is accessible via the HSA e-services page:

hsa.gov.sg/medical-devices/adverse-events

Information required in an AE report​

An adverse event report should include:

  • Details of the reporter (company name, contact person, dealer's licence number);
  • Device identification (device name, model number, lot/serial number, registration number if applicable);
  • Description of the event — what happened, when, where, and to whom;
  • Patient/user information (anonymised — patient identity is not reported to HSA);
  • Suspected cause or mechanism of the event;
  • Actions taken by the company in response (corrective actions, device retrieval, etc.);
  • Assessment of causal relationship between the device and the event.

Official sources​