When to Report Field Safety Corrective Actions in Singapore

1. Overview

Field Safety Corrective Action (FSCA) refers to any action taken to reduce the risk of using a medical device already placed on the market. Manufacturers are required to report FSCAs to the Health Sciences Authority (HSA) when the action is necessary to address unacceptable risks associated with the device. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/when-to-report

2. Situations Requiring FSCA Reporting

Report an FSCA to HSA if the corrective action is initiated because:

• The device presents an unacceptable risk to patients, users, or others.
• The device does not meet its performance claims or intended purpose.
• There is a need to reduce risk through actions such as:
  • Recall or field safety notice
  • Design modification
  • Software update
  • Labelling or instructions for use change
  • Advice to users on specific actions

Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/when-to-report

3. Types of FSCAs

Common FSCAs include:

• Recall — Removal of devices from the market or from use due to safety concerns.
• Field Safety Notice (FSN) — Communication to users about risks and recommended actions without physical removal.
• Design changes — Modifications to the device to eliminate or reduce risk.
• Labelling updates — Changes to warnings, contraindications, or instructions.

All such actions triggered by risk concerns must be reported. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/when-to-report

4. Reporting Timelines

• Report the FSCA to HSA as soon as possible and no later than 2 working days after initiating the action or becoming aware of the need for it.
• Submit the Field Safety Notice (FSN) or equivalent communication together with the report.

Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/when-to-report

5. Reporting Process

• Submit reports via the HSA online portal or designated forms.
• Include details such as the reason for the FSCA, affected devices (model, serial/lot numbers), risk assessment, and corrective actions.
• Manufacturers must also distribute the FSN to relevant parties in Singapore and provide HSA with distribution records.

Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/when-to-report

6. Important Notes

• Overseas manufacturers must report FSCAs that affect devices supplied in Singapore.
• Failure to report mandatory FSCAs may result in regulatory non-compliance.
• HSA may request additional information or coordinate risk communication.
• Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/when-to-report

7. Related Requirements

Refer to the full Field Safety Corrective Action guidance for details on report content, follow-up actions, and effectiveness monitoring. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/when-to-report