Field Safety Corrective Actions — How to Report
Notifying HSA
FSCA reports are submitted to HSA via the SHARE portal or through the dedicated FSCA reporting channel described on the HSA website:
hsa.gov.sg/medical-devices/field-safety-corrective-action/how-to-report
The FSCA report to HSA should include:
- Description of the safety issue and the device(s) affected;
- The scope of the FSCA (which devices, which lots, which markets);
- The corrective action being taken;
- The Field Safety Notice (FSN) to be sent to users and healthcare professionals;
- Distribution records showing which Singapore entities received the affected devices.
The Field Safety Notice (FSN)
A Field Safety Notice is a written communication sent by the manufacturer or registrant to users, healthcare professionals, and distributors to inform them of the FSCA and the actions they must take. The FSN must:
- Clearly identify the device and the safety issue;
- Describe the risk in plain language;
- State clearly what action the recipient must take (e.g. stop using, return, modify);
- Provide contact details for queries;
- Be sent to all relevant parties in Singapore who received the affected devices.
HSA may publish information about the FSCA on its List of Published Risk Communications.