Dear All
The Medical Device Control Office (MDCO) of the Department of Health administers a Medical Device Administrative Control System (MDACS) published the revised guidelines on listing system for the "Medium-risk and high-risk medical devices (i.e. Class II/III/IV) GN-02", and "invitro diagnostics medical devices (IVD)" and other associated documents on their MDCO website.
All applications received by the MDCO on or after 1 Aug 2011 must be complete with the following revised application forms and other applicable revised documents.
1. GN-02 Guidance Notes for Listing Class II/III/IV Medical Devices
2. GN-06 Guidance Notes for Listing In Vitro Diagnostics (IVD) Medical Devices
3. Application form for listing of Class II/III/IV medical devices (Form MD-C2&3&4)
4. Application form for listing of in vitro diagnostics medical devices (Form MD-IVD)
5. Essential Principles Conformity Checklist (MD-CCL)
6. Sample Essential Principles Declaration of Conformity (given in Appendix 3 of GN-02 and GN-06).
For more details please refer here.
Regards
S.Subramaniam
The Medical Device Control Office (MDCO) of the Department of Health administers a Medical Device Administrative Control System (MDACS) published the revised guidelines on listing system for the "Medium-risk and high-risk medical devices (i.e. Class II/III/IV) GN-02", and "invitro diagnostics medical devices (IVD)" and other associated documents on their MDCO website.
All applications received by the MDCO on or after 1 Aug 2011 must be complete with the following revised application forms and other applicable revised documents.
1. GN-02 Guidance Notes for Listing Class II/III/IV Medical Devices
2. GN-06 Guidance Notes for Listing In Vitro Diagnostics (IVD) Medical Devices
3. Application form for listing of Class II/III/IV medical devices (Form MD-C2&3&4)
4. Application form for listing of in vitro diagnostics medical devices (Form MD-IVD)
5. Essential Principles Conformity Checklist (MD-CCL)
6. Sample Essential Principles Declaration of Conformity (given in Appendix 3 of GN-02 and GN-06).
For more details please refer here.
Regards
S.Subramaniam
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