The time required to obtain MDACS (Medical Device Administrative Control System) registration for Class III in vitro diagnostic (IVD) medical devices in Hong Kong typically ranges from 6 to 12 months. The duration can vary depending on several factors, including:

1. Pre-Application Preparation (1 to 3 months)

• Documentation and Compliance: Preparing the necessary technical documentation, establishing a Quality Management System (QMS), and conducting clinical evaluations can take considerable time, particularly for complex devices.

2. Application Submission (1 week)

• Submission Process: The actual submission of the application, including all required documents, usually occurs within a week after preparation.

3. Initial Screening (2 to 4 weeks)

• Completeness Check: After submission, the Medical Device Control Office (MDCO) conducts an initial screening to verify that the application is complete and all necessary documentation is included.

4. Detailed Assessment (3 to 6 months)

• In-Depth Review: This phase involves a thorough evaluation of the technical documentation, clinical data, risk management, and compliance with relevant standards. The duration of this stage can vary based on the complexity of the device and the quality of the submitted documentation.
• Request for Additional Information: If the MDCO identifies gaps or requires clarification, they may issue a request for additional information, which can extend the review timeline by 1 to 2 months depending on how quickly the applicant responds.

5. Final Review and Decision (2 to 4 weeks)

• Decision Making: Once the assessment is complete, the MDCO will make a final decision regarding the approval or rejection of the application. This process typically takes a few weeks.

6. Notification of Outcome (1 week)

• Outcome Communication: After the final review, the MDCO will notify the applicant of the outcome, generally within a week.

Total Estimated Time

Overall, considering the above stages, manufacturers can expect the total timeline for obtaining MDACS registration for Class III IVD devices to be between 6 to 12 months, depending on various factors such as device complexity, submission quality, and responsiveness in addressing any queries from the MDCO.

Conclusion

To expedite the MDACS registration process, it is crucial for manufacturers to ensure thorough preparation of their application materials and maintain clear communication with the MDCO throughout the review process. Engaging regulatory experts can also help streamline this timeline by ensuring compliance with all requirements from the outset.