Singapore – Singapore HSA will require government accreditation for certification bodies issuing ISO 13485 certificates

The Medical Devices Branch of Singapore’s Health Sciences Authority (HSA) has announced, in a webinar held on March 2, that it intends to only issue dealer licenses to companies that can provide either 1) a Medical Device Single Audit Program (MDSAP) certificate, or 2) an ISO 13485 certificate from a third-party certification body (CB) accredited by the Singapore Accreditation Council (SAC). The new requirement is to take effect on January 1, 2025.

SAC accreditation for certification bodies issuing ISO 13485 certificates will no longer be voluntary

CBs in Singapore issuing ISO 13485 certificates for local medical device regulatory purposes may currently opt into the SAC accreditation program, and two CBs have already done so. Starting in 2025, accreditation will be required by the HSA instead of being voluntary. The HSA will observe and assess the performance of CBs during audits. It was stated in the webinar that the assessment program will resemble the process already in use for CBs issuing Good Distribution Practice for Medical Devices (GDPMDS) certification…