The time it takes to obtain 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 breakdown of the timeline involved:

Estimated Timeline for MDACS Registration

1. Preparation Phase:

   • Duration: This phase can take anywhere from a few weeks to several months.
   • During this time, manufacturers gather and prepare the necessary technical documentation, conduct clinical evaluations, ensure compliance with quality management standards (like ISO 13485), and prepare the application for submission.

2. Application Submission:

   • Once the preparation is complete, 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 performs an initial screening to check for completeness and to ensure that all required documents are included in the application.

4. Detailed Evaluation:

   • Duration: This phase generally takes 4 to 8 weeks or longer, depending on the complexity of the device and the number of applications being processed by the MDCO at that time.
   • The MDCO conducts a thorough evaluation of the technical documentation, including clinical data and risk management practices.

5. Response to Requests for Additional Information:

   • If the MDCO requests further information or clarification during the evaluation, the time it takes to gather and submit this information can add several weeks to the overall timeline.

6. Final Decision:

   • After completing the detailed evaluation and addressing any queries, 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 for the decision, and manufacturers may need to address any deficiencies before resubmitting, which can further extend the timeline.

Total Timeframe

• Overall Duration: From the initial preparation to final approval, the entire MDACS registration process typically spans from 2 to 6 months or longer, depending on the complexity of the device, the efficiency of the submission, and any additional requests for information.

Summary

In summary, obtaining MDACS registration for Class IV IVD medical devices can take 2 to 6 months or more, depending on several factors, including preparation time, the thoroughness of the application, and the efficiency of the MDCO review process. Manufacturers are encouraged to ensure that their documentation is complete and compliant to facilitate a smoother and more efficient registration process.