MDACS Issued Documents and Forms Updates

The following Guidance Notes have been updated, and are effective from 29 October 2026:

• [GN-01] Overview of the Medical Device Administrative Control System
• [GN-02] Guidance Notes for Listing Class II/III/IV Medical Devices
• [GN-04] Conformity Assessment Framework and Conformity Assessment Bodies
• [GN-06] Guidance Notes for Listing Class B/C/D In Vitro Diagnostic (IVD) Medical Devices
• [GN-07] Guidance Notes for Listing of Importers of Medical Devices
• [GN-08] Guidance Notes for Listing of Local Manufacturers of Medical Devices
• [GN-09] Guidance Notes for Listing of Distributors of Medical Devices

The following Code of Practice (COPs) have been updated, and are effective from 29 October 2026:

• [COP-01] Code of Practice for Local Responsible Persons
• [COP-02] Code of Practice for Conformity Assessment Bodies
• [COP-03] Code of Practice for Listed Local Manufacturers of Medical Devices
• [COP-04] Code of Practice for Listed Importers of Medical Devices
• [COP-05] Code of Practice for Listed Distributors of Medical Devices

Please refer to the “Summary of Revision” of each issued document for more information.

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.

The Department of Health may from time to time revise issued documents under MDACS. LRP and traders may wish to refer to the website of the Medical Device Division to keep track of the latest updates.