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What's New

What's New

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

The Medical Device Division (MDD) will continue the 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, the content and requirement of this trial scheme had been modified with effect from this date. Only listed local responsible persons (LRP) are eligible to participate in the trial scheme. The modified trial scheme will last until 31 December 2021. Each 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 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

Adobe Reader is required for viewing and printing the Portable Document Format (PDF) documents. To download Adobe Reader, please click here.

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Last Revision Date : 28 December 2020