The Guidance Notes “Guidance Notes for Listing Class II/III/IV Medical Devices” (GN-02) and “Guidance Notes for Listing Class B/C/D In Vitro Diagnostic (IVD) Medical Devices” (GN-06) has been updated and are effective from 31 July 2026.
In the meantime, medical device 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.