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.