The Medical Device Division (MDD) will continue the trial scheme to streamline the application and approval process of Class II/III/IV general medical device listing applications with established support on proven safety and performance. Only listed local responsible persons (LRP) are eligible to participate in the trial scheme.
The trial will last until 31 December 2020. This trial scheme is considered as a transitional step towards enforcing the registration of medical devices in Hong Kong in the future.
The Scheme aims to streamline the application and approval process of Class II/III/IV general medical device listing applications if they meet the following criteria:
a. There are no reported deaths or serious injury associated with the device (local and worldwide)
b. There are no active recalls, field safety corrective actions, or adverse incidents (local and worldwide)
c. Two or more valid, independent regulatory agencies’ approval has been obtained for at least three years. There is at least one substantially equivalent device listed under the Medical Device Administrative Control System (MDACS)
The applicant can make no more than two applications each time. The interested applicant is to duly fill in the application form, sign the declaration form, prepare a device profile, and submit to MDD together with the supporting documents following application procedures in “Guidance Notes for Listing Class II/III /IV Medical Devices” (Guidance Notes: GN-02). Applicants are encouraged to provide soft copies of supporting documents in a portable storage device format as far as possible.
More information could be accessed from the link below:-
Continuance of Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications