The MDACS (Medical Device Administrative Control System) registration process for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong is detailed and requires careful preparation. Here’s a step-by-step guide on the processes involved:

Step-by-Step Process for MDACS Registration

1. Determine Classification:

   • Confirm that your IVD device falls under Class IV. This classification typically applies to high-risk devices that require rigorous regulatory scrutiny.

2. Understand Regulatory Requirements:

   • Familiarize yourself with the Medical Device Ordinance (Cap. 663) and related guidelines provided by the Medical Device Control Office (MDCO). These documents outline the requirements for safety, quality, and effectiveness.

3. Prepare Documentation:

   • Compile all necessary documentation required for the application:
     • Application Form: Complete the MDACS application form specific to Class IV IVD devices.
     • Technical Documentation: This should include:
       • Device description and intended use.
       • Design and manufacturing information.
       • Performance data, including validation and verification data.
       • Risk analysis according to ISO 14971.
     • Clinical Evidence: Provide sufficient clinical data to demonstrate safety and effectiveness.
     • Labeling: Include the proposed label, instructions for use, and any promotional materials.

4. Quality Management System:

   • Ensure compliance with recognized quality management systems (e.g., ISO 13485). This includes having appropriate documentation and processes in place.

5. Submit Application:

   • Submission Method: Submit your application electronically through the MDCO online system or by mail, as specified by the MDCO.
   • Ensure that all documents are complete and formatted as required to avoid delays in processing.

6. Pay Application Fees:

   • Pay the applicable registration fee at the time of application submission. Keep a copy of the payment receipt for your records.

7. Evaluation by MDCO:

   • After submission, the MDCO will conduct a thorough evaluation of your application. This process may involve:
     • Review of submitted documents.
     • Request for additional information or clarification, if necessary.
     • Possible site inspection (for manufacturers) to verify compliance with manufacturing practices.

8. Response to Queries:

   • Be prepared to respond promptly to any queries or requests from the MDCO during the evaluation process.

9. Approval and Issuance of Registration:

   • If the application meets all requirements, the MDCO will grant MDACS registration for your Class IV IVD device. You will receive a certificate or official notification confirming the registration.

10. Post-Market Surveillance:

    • After obtaining registration, ensure compliance with ongoing obligations, including:
      • Reporting adverse events or incidents.
      • Monitoring product performance and safety.
      • Keeping records as required by the MDCO.

11. Renewal and Updates:

    • Stay informed about renewal requirements. Registration may need to be renewed periodically, especially if there are changes to the device or the regulatory framework.

Key Considerations

• Consult Guidelines: Always refer to the latest MDCO guidelines for any specific requirements regarding Class IV IVD devices.
• Seek Professional Help: If necessary, consider engaging regulatory consultants with expertise in medical device registration to assist with the application process.
• Monitor Regulatory Changes: Regulations may evolve, so regularly check the MDCO website for updates and additional information.

By following these steps and thoroughly preparing your documentation, you can successfully navigate the MDACS registration process for Class IV in vitro diagnostic medical devices in Hong Kong.

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