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Listing of Class B and C In Vitro Diagnostic Medical Devices and Revised GN-06 “Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices”

The listing of Class B and C In Vitro Diagnostic Medical Devices (IVDMD) will start on 11 February 2019. Local Responsible Persons (LRP) of Class B or C IVDMD can apply for inclusion of the device into “The List of Medical Devices” under the Medical Device Administrative Control System (MDACS). The information of the devices together with their LRPs will be posted on the webpage https://www.mdco.gov.hk.

The requirements for the listing of IVDMD as well as the application procedures can be found in the updated version of "Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices" [GN-06E (2019)]. Please click here to download the related document and application form. The original copy of the completed application form together with the supporting documents must be submitted, by hand or by mail, to the Medical Device Control Office. Applicants are encouraged to provide softcopies of supporting documents in CD-ROM format as far as possible.

Medical Device Control Office arranges interactive workshop from time to time to help traders in lodging applications to list Class II, III and IV medical devices or Class B, C and D IVDMD under the MDACS. The coming workshop on Application for Listing Class B, C and D IVDMD (Conduct in Cantonese) will be held on 27 February 2019 and the workshop is now open for enrolment. LRP and interested parties are welcome, details please refer to the link here.

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Last Revision Date : 23 January 2019