Reporting Field Safety Corrective Actions to HSA in Singapore

1. Overview

Manufacturers are required to report Field Safety Corrective Actions (FSCA) to the Health Sciences Authority (HSA) in Singapore promptly when corrective measures are taken to address risks associated with medical devices already on the market. This includes submitting the Field Safety Notice (FSN) and relevant details. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/how-to-report

2. Reporting Timeline

Report the FSCA to HSA no later than 2 working days after the FSCA is initiated or when the need for corrective action is identified. Early reporting is encouraged to facilitate timely risk communication. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/how-to-report

3. Required Information for Reporting

The FSCA report must include:

• Manufacturer details (name, contact information)
• Device details (brand name, model, catalogue number, affected serial/lot numbers)
• Reason for the FSCA (description of the issue, risk assessment)
• Type of corrective action (recall, design change, software update, labelling change, etc.)
• Field Safety Notice (FSN) or equivalent communication
• Distribution information in Singapore (consignees, quantities supplied)

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

4. Submission Method

• Submit the report electronically via the HSA online portal or email to the Medical Devices Branch.
• Attach the FSN and any supporting documents (e.g., risk analysis, test reports).
• For overseas manufacturers, the authorised representative in Singapore may assist with submission.

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

5. Field Safety Notice (FSN) Requirements

• The FSN must be clear, concise, and in English.
• Include urgency level, problem description, risk to patients/users, recommended actions, and reply form.
• Manufacturers must distribute the FSN to all relevant consignees in Singapore and provide HSA with proof of distribution.

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

6. Follow-up and Monitoring

• HSA may request additional information or clarification.
• Manufacturers must monitor the effectiveness of the FSCA and submit follow-up reports if required.
• Provide updates on the progress of the corrective action and closure of the FSCA.

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

7. Important Notes

• Timely and complete reporting helps HSA coordinate risk mitigation efforts.
• Non-compliance with reporting requirements may lead to regulatory action.
• Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/how-to-report