Home About Qualtech NEWS HONGKONG: MDCO issued Draft of Guidance Notes for Listing of Local Responsible Person – April, 2019
HONGKONG: MDCO issued Draft of Guidance Notes for Listing of Local Responsible Person – April, 2019

April 11, 2019

MDCO plans to issue a new Guidance Note for Listing of Local Responsible Persons (LRPs). In this regard, MDCO will be held briefing sessions on April 8, 2019. The briefing sessions will be held 3 times in different languages that is in English and 2 times in Cantonese.


In the Draft of Guidance Note for Listing of Local Responsible Person (LRPs), MDCO would like to enact new procedure for LRP Listing in Hong Kong. Previously, LRP is automatically listed in the List of LRP when registering for the first medical device. While, in this Draft, company who would like to become LRP must submit application for LRP Listing and get their company listed under MDCO, prior medical device registration.


This regulation will be applied to Entities who hasn’t been listed under MDCO until this Guidance officially released by MDCO, while Existing LRPs of listed medical devices do not need to apply. The validity period as an LRP is 3 years after approval and must be renewed 3 months before the expiration date through the submission of a renewal application form and requisite documents as specified by the MDCO. The current listing shall remain in effect until there is a decision from MDCO that renewal is must be made.


In addition, in this Draft of Guidance Note also specify the process of taking over the listing of medical devices from another LRP. Agreement between the three parties namely Manufacturer, Existing LRP and New LRP, in this guidance referred to as the Applicant, must be made. The applicant should arrange with the existing LRP and manufacturer of the listed medical devices to be taken over to complete the form MD-LRP Change, a Transfer Form and submit the application to the MDCO.


   In association with the issuance of the new Guidance Notes, the existing COP-01 Code of Practice for Local Responsible Persons will be updated.
With the holding of briefings sessions and the posting of draft guidance notes and materials, participants can take part in giving comments on the plans and contents of the new guidance note regarding Listing of Local Responsible Persons.

HK 2019Apr 1

  

References
Briefing sessions on Proposed Guidance Notes for Listing of Local Responsible Persons
Draft Guidance Notes for Listing of Local Responsible Persons
Draft Code of Practice for Local Responsible Persons (May 2019 Edition)
Briefing material

Tags

Hong Kong Registration, Local Responsible Person

 

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Home About Qualtech NEWS HONGKONG: MDCO issued Draft of Guidance Notes for Listing of Local Responsible Person – April, 2019