Singapore HSA included Medical Device Singapore Audit Program (MDSAP) certification as one of the acceptable lists of Medical Device’s QMS Certifications for medical device dealers (including manufacturer, importer and wholesaler).
Accordingly, below main guidance (as well as the related guidances) were updated:
– GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices,
– GN-15: Guidance on Medical Device Product Registration
Please refer HSA’s weblink to view all updated guidances: https://www.hsa.gov.sg/medical-devices/guidance-documents