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What is the processing time for Class B medical device registration under the Hong Kong MDACS?
Release time：2025-05-16 15:35:45 The author: source:
The processing time for Class B medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) typically ranges from 3 to 6 months. This timeframe depends on factors such as the completeness of your application, the complexity of the device, and the volume of applications being processed by the Medical Device Division (MDD) at the Department of Health.

The processing time for Class B medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) typically ranges from 3 to 6 months. This timeframe depends on factors such as the completeness of your application, the complexity of the device, and the volume of applications being processed by the Medical Device Division (MDD) at the Department of Health.

📌 Key Considerations

  • Application Completeness: Ensure that all required documents are accurately completed and submitted. Incomplete applications may lead to delays.

  • Regulatory Approvals: If your device has prior approvals from recognized regulatory bodies (e.g., CE, FDA), this may expedite the review process.

  • Communication: Maintain open communication with the MDD. If you haven't received an acknowledgment within two weeks of submission, contact them to confirm receipt

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