When medical device products are suspected of being potentially harmful to users, due to nonconformity to quality, safety and performance requirements, they may be subjected to a Field Safety Corrective Action (FSCA). All information related to the FSCA must be reported to HSA.

A guidance document on FSCA is available to industry.

Click here to download the guidance.

Please click on this link to view safety alert notices on medical devices.

Companies can submit FSCA reports to the Medical Device Branch using the following forms:

• FSCA Notification/Preliminary Report Form (MS word) (PDF)
• FSCAFollow-Up or Final Report Form (MS word) (PDF)

Complete the FSCA reporting forms and submit by mail or fax to:

FSCA Reporting
Medical Device Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way, #11-01 Helios
Singapore 138667
Fax: (65) 6478 9028

The time frame for notification of a FSCA, including recalls, is described as “before carrying out the FSCA”. This is satisfied by submitting as much of the FSCA detail as is known within 24 hours of having made the decision to recall.

A preliminary report containing full information on the FSCA must be submitted within 24 hours from the commencement of the FSCA.

Within 21 days from the date of the commencement of the FSCA, a final report is to be submitted to the Authority.