The application cycle for MDACS 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 entire process may take anywhere from 6 months to over a year. Here’s a breakdown of the typical stages in the review process and their associated timelines:

Application Cycle Duration

1. Pre-Submission Preparation: This phase involves gathering necessary documents, conducting internal reviews, and ensuring compliance with all requirements. The duration can vary widely depending on the readiness of the applicant but may take 1 to 3 months.

2. Submission of Application: Once the application package is complete, the submission can occur. The actual submission is typically a one-time event.

3. Initial Screening: After submission, the MDCO conducts an initial screening to ensure that the application is complete. This process usually takes 2 to 4 weeks.

4. Detailed Assessment: Following the initial screening, the MDCO will undertake a comprehensive review of the submitted documentation, including:

   • Technical documentation
   • Clinical evidence
   • Risk management files
   • Quality management system compliance

   The detailed assessment generally takes 3 to 6 months but can vary based on the complexity of the device and any additional information required.

5. Request for Additional Information (if needed): If the MDCO finds gaps or requires clarification, they may request additional information from the applicant. The time for the applicant to respond can add 1 to 2 months to the overall cycle, depending on the speed of the response.

6. Final Review and Decision: After receiving the necessary information, the MDCO will complete the final review and make a decision. This step can take an additional 2 to 4 weeks.

7. Notification of Outcome: Once the review is complete, the MDCO will notify the applicant of the outcome. If approved, the registration will be issued. This notification may occur within 1 week following the final review.

Review Process Stages

1. Initial Screening

   • Ensures completeness and adherence to submission guidelines.
   • Checks for required documents and application form accuracy.

2. Detailed Assessment

   • Thorough evaluation of technical documentation, clinical data, and risk management.
   • Review for compliance with relevant standards (ISO 13485, ISO 14971, etc.).
   • Assessment of the Quality Management System.

3. Request for Additional Information

   • If the MDCO identifies any concerns or missing information, they will issue a request to the applicant for clarification or additional documentation.

4. Final Review

   • A concluding evaluation of the provided information.
   • Final decision-making by regulatory officials on the approval or rejection of the application.

5. Decision Notification

   • Official communication of the outcome, including approval or reasons for rejection.

Conclusion

While the overall application cycle for MDACS registration of Class III IVD devices typically takes 6 months to over a year, the timeline can vary significantly based on several factors. Manufacturers should ensure thorough preparation of the application package and prompt responses to any requests for additional information to help expedite the review process. Regular communication with the MDCO throughout the process can also facilitate a smoother application experience.

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