MDACS Activities

The following documents have been revised and the updated version is the September 2021 Edition. All applications submitted to the MDD on or after 1 December 2021 must be complete with the revised application forms and other applicable revised documents.

1. Application form for listing of Class II/III/IV medical devices (Form MD-C2&3&4)
2. Application form for listing of in vitro diagnostics medical devices (Form MD-IVD)
3. GN-02 Guidance Notes for Listing Class II/III/IV Medical Devices
4. GN-06 Guidance Notes for Listing In Vitro Diagnostics (IVD) Medical Devices

Please click "Application Forms" and "Issued Documents" to download the above documents. Older versions are removed.