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What is the duration of Class B medical device MDACS registration in Hong Kong?
Release time：2025-05-26 16:13:47 The author: source:
The duration of Class B medical device MDACS registration in Hong Kong typically takes around 8 to 14 weeks (about 2 to 3.5 months) from the date of application submission to final approval.

The duration of Class B medical device MDACS registration in Hong Kong typically takes around 8 to 14 weeks (about 2 to 3.5 months) from the date of application submission to final approval.

Breakdown of the timeline:

  • Preparation of application documents: varies based on your readiness (usually 2-4 weeks)

  • Initial screening by Medical Device Division (MDD): about 2-4 weeks

  • Technical review: about 4-8 weeks

  • Approval and issuance of device listing number: about 1-2 weeks after review completion

Important notes:

  • Delays can occur if the application is incomplete or if the MDD requests additional information.

  • Timely and accurate submission and prompt responses to queries can speed up the process.

If you want, I can help you plan the timeline based on your specific device and situation!

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


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