Obtaining 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. This timeframe can vary based on several factors, including:

1. Preparation Time:

   • The duration for preparing and organizing the necessary technical documentation can vary significantly, depending on the complexity of the device and the manufacturer’s readiness.

2. Initial Review:

   • After submission, the initial review by MDACS usually takes about 10 to 14 days to ensure the application is complete.

3. Technical Review:

   • The detailed technical evaluation by the Department of Health generally takes around 60 to 90 days. This involves assessing safety, performance, and regulatory compliance.

4. Response to Queries:

   • If MDACS has questions or requests additional information, the time taken to respond can vary but typically ranges from 10 to 30 days depending on the complexity of the queries.

5. Approval and Issuance:

   • Once approved, the issuance of the registration certificate usually occurs within 1 day.

Summary

Overall, the complete process for obtaining Class II IVD registration in Hong Kong generally spans 3 to 6 months, influenced by preparation time, review stages, and any necessary responses to regulatory queries.

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