Home About Qualtech NEWS SINGAPORE: HSA Releases Updated Guidance on Medical Device Field Safety Correction Action – April, 2019
SINGAPORE: HSA Releases Updated Guidance on Medical Device Field Safety Correction Action – April, 2019

April 11, 2019

There have been 3 revisions that HSA included in the latest GN-10 document. Refer to Table 1 below to see the difference revisions added.

Table. 1 Latest revision for GN-10 is version 3.5 and it shows the following changes from the previous version

1 HSA 2019Apr 1

 

 

Implication of Changes

HSA clarifies that manufacturers who will do MDRR3 reporting for a device that is clinically needed in SG will need to undergo review and approval prior selling. In addition, manufacturer will also submit a MDRR1 report for the same device to HSA.

For FSCAs to be reported under MDRR1, FSNs are required to be copied to relevant officials of the affected healthcare facilities.

 

Clarification through Visuals:

1 HSA 2019Apr 2

 

FSCA Report Submission Flowchart: Illustrates the of report is needed to submit for FSCA Submission. Added the items from GN-10 version 3.5

 

References:
Health Sciences Authority-Regulatory Guidance for GN-10

Tags:
Singapore Registration, Post Market, Guidance Update

 

 

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Home About Qualtech NEWS SINGAPORE: HSA Releases Updated Guidance on Medical Device Field Safety Correction Action – April, 2019