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Singapore: Final Phase for Transition of the ISO 13485 Certification Granted by SAC-Accredited Body for Medical Device Dealer License Applications (w.e.f 1 January 2025)

Updated: Apr 16

Health Sciences Authority issued a reminder about the final transition year for all medical device dealers to obtain confirmation from their designated Certification Bodies (CB) regarding the accreditation by the Singapore Accreditation Council (SAC).

Effectively from 1 January 2025, dealers who wish to use ISO 13485 as their pre-requisite for medical device dealer license application are required to ensure their CBs are accredited by the SAC. Suppose the CB has not gotten accreditation before the dealers’ next cycle of recertification audit within the transition period (2022-2024), dealers are advised to check with the designated CBs on their plan to obtain SAC accreditation or consider changing CBs to the accredited CBs.

Important to take note that HSA only accepts ISO 13485 certificated issued by the SAC accredited CBs or MDSAP certificates for medical device dealer license applications.

Previously in 2021, HSA decided to implement the requirement of the SAC accreditation for CBs that issuing ISO13485 for medical device dealers to ensure the consistency and quality guaranteed throughout the certification process and the ISO13485 certification issued in line with the international medical device regulatory principles.




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