Health Sciences Authority uses a number of post-marketing risk assessment approaches to ensure the continued safe use of medical devices. These measures include reporting from healthcare professionals, mandatory reporting from medical device manufacturers and dealers, and exchange of regulatory information with other medical device regulatory agencies.

The mandatory reporting of adverse events by manufacturers and dealers is an important part of the post-market surveillance system.

A guidance document on adverse event reporting is available to industry.

Click here to download the guidance.

1. Mandatory reporting by medical device dealers

Companies can make reports to the Medical Device Branch using the following form:

• Adverse Event Report Form (MS word) (PDF)

Complete the adverse event reporting form and submit by mail or fax to:

Adverse Event Reporting
Medical Device Branch
Therapeutic Products Divison
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way, #11-01 Helios
Singapore 138667
Fax: (65) 6478 9028

2. Voluntary reporting by healthcare professionals and consumers 

Healthcare professionals and consumers can make reports to the Medical Device Branch using the following form:

• Voluntary Adverse Event Report Form (MS word) (PDF)

Complete the voluntary adverse event reporting form and submit by mail or fax to:

Adverse Event Reporting
Medical Device Branch
Therapeutic Products Divison
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way, #11-01 Helios
Singapore 138667
Fax: (65) 6478 9028

Or email the voluntary report to HSA_medical_device@hsa.gov.sg.

As a general principle, there should be a pre-disposition to report rather than not to report in case of doubt on the reportability of an adverse event. Any adverse event, which meets the three basic reporting criteria listed below, is considered as a reportable adverse event. The criteria are:

• an adverse event (or potential adverse event) has occurred;
• the device product is associated with the adverse event & ;
• the adverse event 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 of patient, user or other person;
  • no death or serious injury occurred but the event might lead to death or serious injury of a patient, user or other person if the event recurs.

The reporting timeline for adverse event reporting for dealers of device products are:

1. within 48 hours for events that represents a serious threat to public health;
2. within 10 days for events that has led to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person;
3. within 30 days for events where a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person

The report should not be unduly delayed if the information is incomplete. The initial report of an adverse event should contain as much relevant detail as is immediately available, but should not be delayed for the sake of gathering additional information.

Dealers of device products are to follow up with a final report within 30 days of the initial report, detailing the investigation into the adverse event. Follow-up reports may be requested as and when necessary.

All Adverse Event Reports are reviewed by HSA for trend analysis.

The Adverse Event Reports may identify unexpected adverse effects. Such findings can lead to changes such as refinement of instruction of use or introduction of specific warnings. When a hazard is considered unacceptable, a medical device may have to be withdrawn from the market.