ISO 13485 and MDSAP Certificates Now Accepted for Dealer's Licence QMS Requirements
From January 2025, the Health Sciences Authority (HSA) updated the QMS evidence requirements for medical device dealer's licence applications. Dealers may now satisfy the QMS requirement by providing either:
- An ISO 13485 certificate issued by a SAC-accredited (Singapore Accreditation Council) certification body, or
- An MDSAP (Medical Device Single Audit Program) audit report or certificate.
Previously, MDSAP participation could reduce the scope of an HSA audit but did not independently satisfy the QMS requirement for all dealer licence classes.
📅 Effective / published: January 2025
Medical device dealers in Singapore holding or applying for a dealer's licence should verify whether their current ISO 13485 certificate is issued by a SAC-accredited body, as certificates from non-SAC bodies do not qualify under this pathway. MDSAP participants should confirm their audit report scope covers Singapore-relevant activities. Review the updated HSA guidance on dealer licensing for the full list of accepted bodies and any transitional arrangements.
View official source (HSA Dealer's Licence) ↗