The processing cycle for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong generally involves several stages, from application submission to final approval. Here’s an overview of the typical processing cycle:

MDACS Registration Processing Cycle

1. Preparation Stage:

   • Duration: Varies (can take weeks to months).
   • Activities:
     • Gather and prepare all necessary documentation, including technical files, clinical data, quality management system (QMS) documentation, and labeling materials.
     • Ensure that the device meets the regulatory requirements for Class IV IVD devices.
     • Conduct internal reviews to verify that all documents are complete and accurate.

2. Application Submission:

   • Duration: Immediate (once documentation is ready).
   • Activities:
     • Submit the completed MDACS application form and all supporting documents either through the MDCO online application portal or by postal mail.
     • Pay the required application fee.

3. Initial Review:

   • Duration: Approximately 30 days.
   • Activities:
     • The Medical Device Control Office (MDCO) conducts an initial review of the application to ensure that all required documents are included and that the application form is properly completed.

4. Detailed Evaluation:

   • Duration: Approximately 60 to 90 days.
   • Activities:
     • MDCO evaluates the technical documentation, clinical evidence, and quality management system.
     • The review may include assessment of safety, effectiveness, and compliance with applicable standards and regulations.
     • If the application is complete and meets all requirements, it will move forward; if additional information is needed, the MDCO will issue queries.

5. Response to Queries:

   • Duration: Varies (can take additional weeks).
   • Activities:
     • If the MDCO requests additional information or clarification, the applicant must respond promptly.
     • This stage can extend the overall processing time, depending on how quickly the applicant can provide the requested information.

6. Final Decision:

   • Duration: Approximately 30 days.
   • Activities:
     • Once all evaluations are complete, the MDCO makes a final decision on the application.
     • If approved, the device is registered, and the applicant receives a certificate of registration.
     • If not approved, the applicant will be informed of the reasons for rejection.

7. Post-Market Surveillance and Compliance:

   • Ongoing: After registration, manufacturers must implement post-market surveillance measures and comply with reporting obligations.
   • Activities include monitoring device performance, reporting adverse events, and maintaining compliance with regulatory requirements.

Summary of Key Timelines

• Preparation Stage: Varies (weeks to months).
• Initial Review: ~30 days.
• Detailed Evaluation: ~60 to 90 days.
• Response to Queries: Varies (weeks).
• Final Decision: ~30 days.

Total Processing Time

Overall, from application submission to registration, the entire processing cycle can take anywhere from 3 to 6 months or longer, depending on the completeness of the application, the responsiveness of the applicant, and whether additional information is requested.

Considerations for Applicants

• Thorough Documentation: To streamline the process, ensure that all documentation is complete and accurately reflects the device’s characteristics.
• Responsive Communication: Be prompt in responding to any queries from the MDCO to avoid unnecessary delays.
• Regular Updates: Stay informed about any changes to regulations or guidelines that may impact the registration process.

By understanding the processing cycle and timelines involved, you can better prepare for the MDACS registration process for your Class IV in vitro diagnostic medical device in Hong Kong.

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