Guidance Notes “Overview of the Medical Device Administrative Control System” (GN-01), “Conformity Assessment Framework and Conformity Assessment Bodies” (GN-04), “Guidance Notes for Listing of Importers of Medical Devices” (GN-07), “Guidance Notes for Listing of Local Manufacturers of Medical Devices” (GN-08), “Guidance Notes for Listing of Distributors of Medical Devices” (GN-09) and the respective Code of Practice (COP-01, COP-02, COP-03, COP-04, COP-05) have been updated, and are effective from 1 September 2026.
In the meantime, the listing applications already submitted via the MDIS will not be affected by the aforementioned change. Applicants need not re-submit any applications.
Please click here to view the issued documents.