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How long does it take to obtain Class B medical device registration under the Hong Kong MDACS?
Release time：2025-05-16 15:49:16 The author: source:
The typical processing time to obtain Class B medical device registration under the Hong Kong MDACS is about 60 to 90 working days (approximately 3 to 4 months) after submitting a complete application.

The typical processing time to obtain Class B medical device registration under the Hong Kong MDACS is about 60 to 90 working days (approximately 3 to 4 months) after submitting a complete application.

Factors Influencing Processing Time:

  • Completeness and quality of application documents: Missing or unclear documents can cause delays.

  • Additional information requests: The Medical Device Division (MDD) may request clarifications or extra data.

  • Device complexity: More complex devices might require longer technical evaluations.

Tips to Speed Up the Process:

  • Prepare thorough and accurate documentation.

  • Ensure your Local Responsible Person (LRP) is reachable for prompt communication.

  • Respond quickly to any MDD queries.

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