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Field Safety Corrective Actions — How to Report

Notifying HSA​

FSCA reports are submitted to HSA through the product registration system. Manufacturers and registrants should confirm the current submission method by visiting: hsa.gov.sg/medical-devices/field-safety-corrective-action/how-to-report Standardly, FSCAs are submitted using the same portal or system through which the device was originally registered.

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.

Official sources​

FSCAs related to serious safety issues should be reported to HSA without delay. While no specific maximum timeframe is prescribed in the regulations, companies should submit FSCA notifications as soon as they have assessed the safety issue and determined corrective action is necessary. For life-threatening or immediately dangerous situations, contact HSA directly before submitting a formal report.