Singapore: Fifth Revision of Singapore’s Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices
The Health Sciences Authority of Singapore (HSA) has revised the GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices as of 31 July 2023. This guidance will be applicable to any entity who performs manufacturing, importing, and supplying by wholesale of the medical devices.
The following are the highlights of the guidance revision:
- Medical Device Single Audit Program (MDSAP) certificate is an addition to the current list of acceptable QMS certificates for manufacturers, importers and wholesalers of medical devices.
- For companies using ISO 13485 or MDSAP as QMS certification:
a. The scope must include distribution of the category of medical devices and the type of activities performed.
b. The scope must include medical devices requiring cold-chain management (where applicable).
c. Change notification submission for registered products is required if there is a change in QMS.
- Refurbishing activities and refurbished medical devices:
a. Clarifications on the definition and types of refurbish activities in relation to medical devices are made.
b. A manufacturing license is required for company that deals with refurbishing of medical devices and reprocessing of single use devices.
- Although secondary assembly is considered a manufacturing activity, a manufacturing license is not required if company:
a. Holds an importer’s license or wholesaler’s license; and
Complies with SS 620: Singapore Standard for GDPMDS including secondary assembly clauses or ISO 13485.
- Dealer’s license amendment is required for changes pertaining to:
a. Quality Systems (QS) certificates e.g., ISO 13485, MDSAP or GDPMDS
b. Operating sites address(es)/premises of 3rd party logistics service providers/outsourced activities related to QS certificates.
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