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Health Sciences Authority
Regulatory Updates

Industry Briefing (March 2016)

Audiences

Healthcare professional

Industry member

Product type

Medical devices

5 April 2016

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

[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] (opens in new tab)

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 (opens in new tab) 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.