The cycle for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) typically takes about 3 to 6 months. The duration can vary based on several factors, including the complexity of the device, the completeness of the application, and the responsiveness of the applicant to any queries from the regulatory authorities.

Breakdown of the Time Cycle:

1. Preparation Phase:

   • This can take several weeks to months, depending on how quickly the necessary technical documentation is gathered and organized.

2. Initial Review:

   • After submission, the initial review by MDACS usually takes about 10 to 14 days to check for completeness and correctness.

3. Technical Review:

   • The detailed technical evaluation typically takes around 60 to 90 days. This phase includes the assessment of safety, performance data, and compliance with regulatory requirements.

4. Response to Queries (if applicable):

   • If the MDACS raises questions or requests additional information, the response time can vary, generally taking 10 to 30 days depending on the complexity of the queries.

5. Approval and Issuance:

   • Once the application is approved, the issuance of the registration certificate usually takes 1 day.

Summary

Overall, the complete registration cycle for Class II IVDs in Hong Kong generally spans 3 to 6 months, depending on various factors affecting the preparation and review process.