HomeRegulatory NewsSingapore HSA Revises FSCA Related Guidances for Medical Device GN-09 and GN-10

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01 Aug 2025

Singapore HSA Revises FSCA Related Guidances for Medical Device GN-09 and GN-10

Singapore Health Sciences Authority (HSA) revises guidance documents related to Medical Device Field Safety Corrective Action (FSCA).

Detail of the updates are indicated in the newly released Guidance documents listed below:-

– GN-09 Guidance on the Component Elements of a Dear Healthcare Professional Letter

– GN-10 Guidance on Medical Device Field Safety Corrective Action have been released.

To view the latest guidance’s, please refer to HSA website link:

https://www.hsa.gov.sg/medical-devices/guidance-documents

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Singapore HSA Revises FSCA Related Guidances for Medical Device GN-09 and GN-10

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