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Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications

The Medical Device Control Office (MDCO) will launch a trial scheme to streamline 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 into the trial scheme. The trial will commence from 1 September 2019 to 30 June 2020. The applicant can make no more than two applications each time.

If you are interested in this trial scheme, please duly fill in the application form, sign the declaration form, prepare a device profile, and submit to MDCO 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 softcopies of supporting documents in CD-ROM format as far as possible.

Applicant can download the application form from our website. For detailed conditions of the trial scheme, declaration form and sample layout of device profile, please download from the below links.

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Last Revision Date : 20 August 2019