License Holder LRP, Submission for IVDMD & Regulation soon in Hong Kong

Listing of LRP

Hong Kong's Medical Device Control Office (MDCO) has plans to issue new Guidance Notes on the Listing of Local Responsible Persons (LRPs). The application for listing of LRP applies to entities intending to submit applications for listing their first medical device under the Medical Device Administrative Control System. Existing LRPs of listed medical devices do not need to apply for the listing.

For more information, check out the following link:

-Briefing sessions on Proposed Guidance Notes for Listing of Local Responsible Persons

Listing of Class B and C In Vitro Diagnostics Medical Devices (IVDMD)

The listing of Class B and C In Vitro Diagnostic Medical Devices (IVDMD) has been effective since 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).

For more information, check out the following link:

-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”

Medical Device Regulation

There is news that mandatory regulation for MD and IVD are likely to be enacted at the end of 2019.

For more information, please contact ARQon Hong Kong office. Prof Albert Poon (ex-HK MDCO director) from our team will be assisting you.

Contact us at info@arqon.com.