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What is the processing time for Class IV medical device registration under Hong Kong MDACS?
Release time：2025-04-30 15:31:27 The author: source:
​The processing time for Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) varies depending on several factors, including the completeness of the application and the complexity of the device. While specific timelines are not publicly detailed, the Medical Device Division (MDD) has established an Expedited Approval Scheme for Class II, III, and IV general medical devices.​

Expedited Approval Scheme for Class IV Devices

Under this scheme, applications may be processed more swiftly if certain conditions are met:

  • No reported deaths or serious injuries associated with the device, both locally and worldwide.

  • No active recalls, field safety corrective actions, or adverse incidents related to the device, locally and worldwide.

  • Approval from at least two independent regulatory agencies, such as the U.S. FDA, EU CE, TGA (Australia), Health Canada, or Japan's PMDA/MHLW.

If these criteria are satisfied, the MDD may expedite the review process. Applicants are required to respond to any issues raised by the MDD within two weeks after receiving notice

General Processing Time

For applications that do not qualify for expedited processing, the general processing time can range from 2 to 6 months, depending on the volume of applications and the need for additional information.

Submission Details

Applications should be submitted to:

Medical Device Division (MDD)
Department of Health
Units 2–3, 11/F, Energy Plaza
92 Granville Road
Tsim Sha Tsui East, Kowloon
Hong Kong

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Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


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