The duration for B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong can vary based on several factors, including the completeness of the application, the complexity of the device, and the efficiency of the review process by the Medical Device Control Office (MDCO). However, here are some general timelines:

Typical Duration for B-Class Medical Device MDACS Registration

1. Application Preparation:

   • This phase depends on the manufacturer’s readiness and the complexity of the device. It may take several weeks to months to prepare all the necessary documentation, including technical files, labeling, and risk assessments.

2. Initial Review by MDCO:

   • Processing Time: Once the application is submitted, the initial review by the MDCO usually takes about 1 to 3 months. This timeframe can vary depending on the completeness of the submitted documents and whether any additional information is required.

3. Evaluation Process:

   • The technical evaluation, which includes reviewing the submitted data, may take another 1 to 3 months. If the MDCO finds any deficiencies or requires further clarifications, this could extend the review time.

4. Total Duration:

   • In general, the entire registration process from application submission to receiving the approval and registration certificate can take approximately 2 to 6 months. However, it can be longer if there are delays in communication, requests for additional information, or other unforeseen issues.

Key Factors Influencing Duration

• Completeness of Application: A well-prepared application with complete and accurate documentation will typically lead to a quicker review process.
• Complexity of the Device: More complex devices may require additional evaluations, which can extend the review time.
• MDCO Workload: The number of applications the MDCO is processing at any given time can also impact how quickly they can complete reviews.

Conclusion

While the general timeframe for B-class medical device MDACS registration is between 2 to 6 months, it is important for manufacturers to prepare thoroughly to minimize delays and ensure a smooth registration process. Regular communication with the MDCO and prompt responses to any requests for additional information can also help in expediting the process.

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