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How long does it take to apply for Class B medical device registration under the Hong Kong MDACS? What are the review stages?
Release time：2025-05-16 15:41:52 The author: source:
Typical processing time: Around 4 to 8 weeks after a complete application submission.

Application Duration and Review Stages for Class B Medical Device Registration under Hong Kong MDACS

How Long Does It Take?

  • Typical processing time: Around 4 to 8 weeks after a complete application submission.

  • The exact duration depends on:

    • Completeness and accuracy of submitted documents

    • Whether additional information or clarification is requested

    • Workload and processing capacity of the Medical Device Division (MDD)

Review Stages

StageDescriptionTypical Duration
1. Initial ScreeningVerify that the application form and documents are complete and meet basic requirements.1–2 weeks
2. Technical ReviewDetailed evaluation of technical files, safety data, labeling, and compliance with standards.2–4 weeks
3. Clarification RequestsIf needed, MDD may request additional documents or clarifications from the applicant or LRP.Variable (depends on response time)
4. Final ApprovalMDD issues registration confirmation and assigns registration number.1 week

Notes:

  • Delays often arise if the submitted technical documentation is incomplete or if responses to queries take a long time.

  • Early communication with the Local Responsible Person and careful preparation can help shorten the review timeline.

If you want, I can help you prepare a checklist to ensure your submission is complete and avoid delays. Would you like that?

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


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