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 recall. All information related to the recall must be reported to HSA.
A guidance document on field safety correction action is available to industry.
Click here to download the guidance.
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How to Report?
Companies can make reports to the Medical Device Branch using the following forms:
Complete the field safety corrective action reporting forms and submit by mail or fax to:
Field Safety Corrective Action Reporting
Medical Device Branch
Therapeutic Products Divison
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way, #11-01 Helios
Singapore 138667
Fax: (65) 6478 9028
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When to Report?
The time frame for notification of a recall is described as “before carrying out the recall”. This is satisfied by submitting as much of the recall detail as is known within 24 hours of having made the decision to recall.
A preliminary report containing full information on the recall must be submitted within 24 hours from the commencement of the recall.
Within 21 days from the date of the commencement of the recall, a final report is to be submitted to the Authority.
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