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Does Class B medical device registration under the Hong Kong MDACS require annual renewal?
Release time：2025-05-16 15:48:46 The author: source:
No, Class B medical device registration under the Hong Kong MDACS does not require annual renewal.

No, Class B medical device registration under the Hong Kong MDACS does not require annual renewal.

Key Points:

  • The registration is generally valid for 5 years from the date of approval.

  • Renewal is required every 5 years, not annually.

  • You must submit a renewal application and pay the applicable fees before the registration expires to maintain your device’s registration status.

If you want, I can provide details on the renewal process or important timelines to track. Would that be helpful?

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