What to report
As a general principle, there should be a pre-disposition to report rather than not to report in case of doubt. Any adverse event (AE), which meets the three basic reporting criteria listed below, is considered as a reportable adverse event:
- An AE (or potential AE) has occurred.
- The medical device is associated with the AE.
- The AE leads to one of the following outcomes:
- It becomes a serious threat to public health.
- The death of a patient, user or other person.
- Serious deterioration in state of health of patient, user or other person.
- There is no death or serious injury in the initial AE but it might lead to death or serious injury of a patient, user or other person if the AE recurs.
How to report
The initial report of an adverse event should contain as much detail as possible, and should not be delayed for the sake of gathering more information. If more than one dealer is involved in a reportable AE, each one must submit their own report.
Adverse event reporting
Submit the Mandatory Medical Device Adverse Event Reporting Form for Medical Device Dealers198 KB through e-mail. Keep the email size under 2MB.
Refer to our guides if you are reporting an adverse event:
When to report
It is mandatory for medical device companies, including product registrants, manufacturers, importers and suppliers, to report any AEs related to the medical devices they deal in.
The following medical device-associated AEs must be reported to us:
|Serious threat to public health
|Serious deterioration in state of health
|Possible death or serious injury if the adverse event were to recur
The clock for reporting starts as soon as any personnel in your company, including sales representatives, are made aware of the AE. If there is uncertainty about whether the AE is reportable, you should still submit a report within the time frame stated.
Dealers of medical devices 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.
Note: Adverse events that occur outside of Singapore, but where the medical devices have also been supplied in Singapore, do not require reporting. It will only have to be reported if the registration or licence conditions of those medical devices require so, or if a notice requesting for adverse event information has been issued by us.