MDACS Activities

MDACS Activities

The current phase of Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications will close by year end

25 Oct 2021

The current phase of trial scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications will close on 31 December 2021. Starting from 1 November 2021, the current limit of application for applicants will be lifted.

If you are interested in this trial scheme, please duly fill in the application form (MD-C2&3&4), 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 softcopies of supporting documents in portable storage device 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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