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This application is a service of the Singapore Government.

Health Sciences Authority

Adverse Event Reporting

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.

How to Report?

1. Mandatory reporting by medical device dealers

Clinical trial (CT) adverse event reporting

For CT adverse event reporting, please refer to the Guidelines on Adverse Event Reporting in Medical Device Clinical Trial.

Adverse event reporting not related to clinical trials

For adverse event reporting, dealers should submit reports using the following form:

  • MDAR1 Form: Mandatory Medical Device Adverse Event Reporting Form for Medical Device Dealers (MS word) (Interactive PDF)

Either the PDF or MS word version is to be submitted, not both. The completed form may be submitted via email to hsa_medical_device@hsa.gov.sg.
 

2. Voluntary reporting by medical device users

Medical device users, inlcuding healthcare professionals and consumers, are encouraged to submit reports using the following form:

Either the PDF or MS word version is to be submitted, not both. The completed form may be submitted via email to hsa_medical_device@hsa.gov.sg.

What to Report?

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.

When to Report?

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.

What Happens to the Report?

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

What Regulatory Actions can HSA take?

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.