Field Safety Corrective Action reporting

  1. How to report

How to report

Follow these steps in making a report for a Field Safety Corrective Action to ensure all appropriate actions are swiftly taken for the affected medical devices.

Types of FSCA reporting

For affected medical devices manufactured or supplied in Singapore (MDRR1)

Before initiating the FSCA in Singapore, submit a Notification Report to HSA using the FSCA Notification/ Preliminary Report Form (MDRR1 form)459 KB. Some information (e.g. distribution chains and batch size) may not be available immediately, but do not delay in notifying HSA.

After initiating the FSCA, submit a Final Report within 21 days. If the FSCA has not been completed, submit a follow-up report at the 21st day mark. This is done using the FSCA Final Report Form (MDRR2 form)400 KB

For affected medical devices that are registered or have special authorisation but have not yet been supplied in Singapore (MDRR3)

If affected devices have not been manufactured, imported or supplied in Singapore, but have obtained marketing authorisation in Singapore OR affected devices have been imported but not supplied in Singapore, the Post-market Information Report (MDRR3 form)414 KB should be submitted to the Authority.

Submit the MDRR3 report form within 30 days of initiating the FSCA in any country globally.  

How to submit

All FSCA Reports must be completed with the signatory and date. E-mail the scanned copy of the completed FSCA Report to hsa_medical_device@hsa.gov.sg together with other required documents. E-mail size should be no more than 2MB, otherwise split the email accordingly. 

HSA reserves the right to reject reports that have not been received in the form or manner it prescribes.

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