The cycle for MDACS (Medical Device Administrative Control System) registration of Class III 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 responsiveness of the applicant. Generally, the overall registration process can take 6 to 12 months. Here’s a breakdown of the timeline associated with each phase of the registration process:

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

• Gathering Documentation: This includes developing a Quality Management System (QMS), compiling technical documentation, conducting clinical evaluations, and preparing risk management files.
• Quality System Implementation: Establishing a compliant QMS (ISO 13485) can take time depending on the organization’s existing processes and resources.

2. Application Submission (1 week)

• Submission of Application Package: Once the application is prepared, the actual submission of the application package to the Medical Device Control Office (MDCO) can typically occur within a week.

3. Initial Screening (2 to 4 weeks)

• Completeness Check: The MDCO conducts an initial screening to ensure that all necessary documents and information are included in the application.

4. Detailed Assessment (3 to 6 months)

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

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

• Decision Making: After assessing all documentation and any additional information provided, the MDCO will make a final decision regarding the approval or rejection of the application.

6. Notification of Outcome (1 week)

• Outcome Communication: Once the review is complete, the MDCO will notify the applicant of the outcome, which typically occurs within a week after the final review.

Total Estimated Time

In total, the MDACS registration cycle for Class III IVD devices usually spans 6 to 12 months, depending on various factors such as the device's complexity, the quality of the submission, and the efficiency of communication between the applicant and the MDCO.

Conclusion

While the estimated timeframe provides a general guideline, it's essential for manufacturers to be well-prepared and ensure the completeness and quality of their application to help expedite the review process. Engaging with regulatory affairs experts and maintaining proactive communication with the MDCO can also facilitate a smoother and faster registration experience.

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