Field Safety Corrective 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 email@example.com
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.