Revised GN-02 (Guidance Notes for Listing Class II/III/IV Medical Devices), GN-06 (Guidance Notes for Listing In Vitro Diagnostics (IVD) Medical Devices) and associated documents are issued.
The following documents have been revised and the updated version is the Jul 2011 Edition. All applications received by the MDCO on or after 1 Aug 2011 must be complete with the revised application forms and other applicable revised documents.
- GN-02 Guidance Notes for Listing Class II/III/IV Medical Devices
- GN-06 Guidance Notes for Listing In Vitro Diagnostics (IVD) Medical Devices
- Application form for listing of Class II/III/IV medical devices (Form MD-C2&3&4)
- Application form for listing of in vitro diagnostics medical devices (Form MD-IVD)
- Essential Principles Conformity Checklist (MD-CCL)
- Sample Essential Principles Declaration of Conformity (given in Appendix 3 of GN-02 and GN-06).
Please click "Issued Documents" and “Application Forms” to download them. The current version will be replaced and removed from website after 1 August 2011.