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
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.
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.
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