The cycle for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices 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. Here’s a general outline of the expected timeline involved in the registration cycle:

Estimated Timeline for MDACS Registration

1. Preparation Phase:

   • Duration: This phase can take anywhere from a few weeks to several months.
   • Activities include gathering necessary technical documentation, conducting clinical evaluations, ensuring compliance with quality management system standards (ISO 13485), and preparing the application.

2. Application Submission:

   • After preparation, the application is submitted to the Medical Device Control Office (MDCO).

3. Initial Review by MDCO:

   • Duration: Typically takes 4 to 6 weeks.
   • The MDCO will perform an initial screening to ensure all required documents are included and that the application meets basic regulatory requirements.

4. Detailed Evaluation:

   • Duration: This can take 4 to 8 weeks or longer, depending on the complexity of the device and the volume of applications being processed.
   • During this phase, the MDCO conducts a thorough review of the technical documentation, including assessing clinical data and risk management practices.

5. Response to Queries:

   • If the MDCO has questions or requests additional information during the evaluation, manufacturers must respond promptly. The time taken to gather and submit this information can add several weeks to the overall timeline.

6. Final Decision:

   • After the detailed evaluation, the MDCO will make a final decision regarding the application.
   • Approval: If approved, a registration certificate will be issued, allowing the device to be marketed in Hong Kong.
   • Rejection: If not approved, the MDCO will provide reasons, and manufacturers may need to address issues and resubmit, which can significantly extend the timeline.

7. Total Cycle Duration:

   • Overall Timeframe: From preparation to final approval, the entire MDACS registration process can take anywhere from 2 to 6 months or more, depending on various factors mentioned above.

Summary

In summary, the MDACS registration cycle for Class IV in vitro diagnostic medical devices typically spans from 2 to 6 months or longer, factoring in preparation, review, and any potential follow-up requests for additional information. Manufacturers should plan accordingly, ensuring that their documentation is complete and compliant to facilitate a smoother and more efficient registration process.

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