Adverse Event Reporting for Medical Devices in Singapore

1. Overview

All parties involved in the supply chain of medical devices in Singapore — including manufacturers, importers, suppliers, and healthcare professionals — have a legal obligation to report adverse events to the Health Sciences Authority (HSA). Timely reporting helps HSA monitor device safety, identify potential issues, and take necessary regulatory actions. Source: https://www.hsa.gov.sg/medical-devices/adverse-events

2. Who Must Report

Mandatory reporting applies to:

• Manufacturers (local and overseas)
• Authorised representatives
• Importers
• Suppliers/wholesalers
• Healthcare professionals (doctors, nurses, pharmacists, etc.)
• Healthcare institutions

Voluntary reports from patients or the public are also accepted and encouraged. Source: https://www.hsa.gov.sg/medical-devices/adverse-events

3. Reportable Events

Serious adverse events must be reported, including:

• Death or life-threatening injury
• Permanent impairment of a body function or permanent structural damage
• Hospitalisation or prolongation of existing hospitalisation
• Congenital anomaly/birth defect
• Other medically important events that may jeopardise the patient

Non-serious events and near misses may be reported voluntarily. Source: https://www.hsa.gov.sg/medical-devices/adverse-events

4. Reporting Timelines

• Serious adverse events that result in or contribute to death or serious deterioration in health must be reported within 10 days of becoming aware.
• Other reportable events should be reported as soon as possible, preferably within 30 days.
• Overseas manufacturers must report events known to them that occurred in Singapore.

Source: https://www.hsa.gov.sg/medical-devices/adverse-events

5. How to Report

Adverse events can be reported online via the HSA Adverse Event Reporting portal or by submitting the Medical Device Adverse Event Report Form. Detailed instructions and forms are available on the HSA website. Source: https://www.hsa.gov.sg/medical-devices/adverse-events

6. Additional Obligations for Manufacturers

• Manufacturers must investigate reported events and submit follow-up reports if new information becomes available.
• Trend reporting may be required for recurring non-serious events that indicate potential safety concerns.
• Field safety corrective actions (recalls) must also be reported and coordinated with HSA.

Source: https://www.hsa.gov.sg/medical-devices/adverse-events

7. Important Notes

• Reports are treated confidentially and used for safety monitoring purposes.
• Failure to report mandatory events may result in regulatory action.
• HSA may request additional information or follow-up from reporters.
• Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/adverse-events