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Is annual review required for Class B medical device MDACS registration in Hong Kong?
Release time：2025-05-26 16:14:58 The author: source:
Once your Class B medical device is registered (listed) with MDACS, the registration is valid indefinitely unless you voluntarily cancel it or your device status changes.

No, there is no formal annual review or renewal required for Class B medical device MDACS registration in Hong Kong.

Key points:

  • Once your Class B medical device is registered (listed) with MDACS, the registration is valid indefinitely unless you voluntarily cancel it or your device status changes.

  • However, you must maintain ongoing compliance with regulations, including:

    • Reporting adverse events or device malfunctions.

    • Notifying the Medical Device Division (MDD) of any significant changes to the device or its labeling.

    • Keeping your Local Responsible Person details updated.

So while no yearly renewal or re-registration is mandated, you do have post-market responsibilities to ensure continued compliance.

If you want, I can help you set up a post-market surveillance and reporting plan!

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Contact Us：

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


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