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How long is the registration period for Class B medical device registration under the Hong Kong MDACS?
Release time：2025-05-16 15:47:52 The author: source:
After the 5-year validity, the registration must be renewed to remain valid for marketing and distribution in Hong Kong.

The registration period for Class B medical device registration under the Hong Kong MDACS typically lasts for 5 years from the date of approval.

Additional Notes:

  • After the 5-year validity, the registration must be renewed to remain valid for marketing and distribution in Hong Kong.

  • Renewal involves submitting updated documentation and paying renewal fees as required by the Medical Device Division.

  • It’s important to keep track of the expiry date and prepare renewal applications in advance to avoid disruption.

If you want, I can provide details on the renewal process or reminders on how to manage registration timelines. Would you like that?

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