The time it takes to obtain B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong can vary based on several factors, including the complexity of the device, the completeness of the application, and the efficiency of the review process by the Medical Device Control Office (MDCO). Here’s a general breakdown of the timeline:

Estimated Timeline for B-Class Medical Device MDACS Registration

1. Preparation of Application Documents:

   • Duration: This phase can take several weeks to a few months depending on how quickly the manufacturer can compile the necessary documentation (e.g., technical files, risk assessments, labeling, etc.).

2. Initial Review by MDCO:

   • Duration: Once the application is submitted, the MDCO typically takes 1 to 3 months for the initial review. This duration may vary based on the completeness of the submission and the complexity of the device.

3. Technical Evaluation:

   • Duration: The technical evaluation process, where the MDCO assesses the submitted documentation, can take an additional 1 to 3 months. If there are any deficiencies or additional information is required, this period may extend further.

4. Total Duration:

   • In total, the entire process from preparation to receiving the approval and registration certificate generally takes approximately 2 to 6 months. However, in some cases, it may take longer if complications arise during the review process or if further information is requested.

Key Factors Influencing Duration

• Completeness of Application: A well-prepared and comprehensive application can significantly speed up the review process.
• Complexity of the Device: More complex devices may require more extensive evaluation, leading to longer review times.
• MDCO Workload: The volume of applications being processed by the MDCO at any given time can also affect how quickly they can complete reviews.

Conclusion

While the estimated duration for obtaining B-class medical device MDACS registration is generally between 2 to 6 months, manufacturers should prepare thoroughly to ensure a smooth and efficient registration process. Timely communication with the MDCO and prompt responses to any requests for additional information can also help expedite the timeline.

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