Post-market Information Reporting
When to Report?
This Report Form is to be submitted when post-market information (e.g. product defect, complaints, etc) on medical devices has been requested by the Authority.
If a medical device is affected by the Field Safety Corrective Action (FSCA) but have not been manufactured, imported or supplied in Singapore, OR have been imported but not supplied in Singapore, medical device dealers is required to notify the Authority using this Report Form, within 30 days of the FSCA initiation in any country globally.
For more information on the requirements of FSCA reporting, please refer to the Guidance on Medical Device Field Safety Corrective Action.
How to Report?
Medical device dealers should submit the post-market information reporting form to the Medical Device Branch using the following form:
- MDRR3 Form: Medical Device Post-Market Information Report Form (MS word)
The completed FSCA reporting forms should be submitted by email to email@example.com
Or alternatively the reports may be submitted by postal mail or fax to:
Medical Device Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way, #11-01 Helios
Fax: (65) 6478 9028