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This application is a service of the Singapore Government.

Health Sciences Authority

Field Safety Corrective Action

field_safety_action

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.

How to Report?

Affected devices have been manufactured, or supplied in Singapore

Medical device dealers should submit FSCA reports to the Medical Device Branch using the following forms:

  • MDRR1 Form: FSCA Notification/Preliminary Report Form (MS word)
  • MDRR2 Form: FSCA Follow-Up or Final Report Form (MS word)

The completed FSCA reporting forms should be submitted by email or to hsa_medical_device@hsa.gov.sg

Or alternatively the reports may be submitted by postal 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

 

Affected devices have NOT been manufactured, imported or supplied in Singapore but have marketing authorisation, OR affected devices have been imported but not supplied in Singapore

If affected devices have not been manufactured, imported or supplied in Singapore, but have obtained marketing authorisation in Singapore OR affected devices have been imported but not supplied in Singapore, the MDRR3 report form should be submitted to the Authority.

When to Report?

Notification of a FSCA to HSA should be performed before the initiation of the FSCA in Singapore.

FSCA that falls under MDRR3 reporting should be submitted within 30 days of the intiation in any country globally.

If requested, a preliminary report containing full information on the FSCA shall be submitted within 24 hours after 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. If the FSCA has not been completed, a follow-up report submission at the 21st day mark shall be required.

List of Product Owner's Field Safety Notices

Please click here to view the Field Safety Notices submitted for the FSCAs reported to HSA.