Hong Kong MDCO reveals Trial Scheme to speed up Medical Device Registrations

September 18, 2018

MDCO has proposed a trial scheme for provisional approvals of Class II/III/IV Medical Devices. A list of criteria has to be fulfilled before approval. These criteria will help in shortening the approval time needed for medical device registration in Hong Kong: 

  • No safety issues associated with the device globally

  • Two or more independent regulatory agencies’ approval have been obtained out of the 5 GHTF founding countries

  • Dual track application system

  • The applicant shall respond to any issues raised by using the application dossier submitted, without

  • supplementary submissions

  • All issues raised should be effectively addressed to satisfaction of MDCO within the date specified

Other updates include:

 

Listing application of medical devices under the MDACS

A trial to study the feasibility of LRP to demonstrate their medical devices' conformation to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004). They are required to present valid marketing approvals obtained from the China Food and Drug Administration, as part of the conformity assessment requirements of the MDACS.

 

Revised GN-07

All applications received on or after 1 June 2018 must be completed with the revised application form.

Existing Importers are required to submit supplement information to demonstrate their compliance to the new requirements before 1 June 2019.

 

Contact us at info@arqon.com.

 

 

 

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