Regulatory Updates
Industry Briefing (March 2016)
Audiences
Healthcare professional
Industry member
Product type
Medical devices
5 April 2016
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[Updated on 05 April 2016]
HSA conducted a briefing on updates to Field Safety Corrective Action (FSCA) reporting on 28 and 29 March 2016.
The presentation slides are attached below:
HSA Industry Briefing_FSCA Updates Slides [PDF, 776 KB]
The updated documents related to the refinements of FSCA process are attached below:
GN-09-R3 Guidance on the Component Elements of a Dear Healthcare Professional Letter DRAFT [pdf]
GN-10-R3 Guidance on Medical Device Field Safety Corrective Action DRAFT [pdf]
MDRR1 reporting form DRAFT [doc]
MDRR3 reporting form DRAFT [doc]
For any comments or feedback on the above documents, please email us at hsa_medical_device@hsa.gov.sg by 13 April 2016.
Please use the feedback template attached below and include in the email subject header “FSCA process refinements feedback”.
FSCA process refinements feedback template [xls]
The finalized documents will be in use for FSCAs notified from 18 April 2016 onwards.