Hong Kong MDCO issues revised guidelines on listing system for the Medical Devices

bio_subbu

Super Moderator
#1
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
 

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ThasYuwa

Inactive Registered Visitor
#2
Re: Hong Kong MDCO issues revised guidelines on listing system for the Medical Device

Subbu,
thank you for the great summary. If our devices already have US FDA 510k clearance, does that reduce the documentation burden in any way?
Cheers
 
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