To apply for Class III in vitro diagnostic medical devices (IVDs) registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, follow these steps:

1. Determine Device Classification: Confirm that your IVD is classified as Class III based on its intended use and risk assessment.

2. Prepare Documentation: Gather necessary documents, including:

   • Product description and intended use.
   • Quality management system documentation (e.g., ISO 13485 certification).
   • Evidence of safety and effectiveness (clinical data).
   • Labeling and packaging information.

3. Application Form: Complete the MDACS application form. Ensure all sections are filled accurately, including details about the manufacturer and device specifications.

4. Submission: Submit the application and all required documents to the Medical Device Control Office (MDCO). This can typically be done online or by mail.

5. Application Fee: Pay the relevant fees for the application process. Check the MDCO website for the current fee structure.

6. Review Process: Once submitted, your application will undergo a review. Be prepared to respond to any inquiries or provide additional information if requested.

7. Approval: If your application is successful, you will receive an MDACS certificate, allowing you to market your Class III IVD in Hong Kong.

8. Post-Market Surveillance: After registration, ensure compliance with post-market obligations, including reporting adverse events and maintaining quality standards.

For the most current guidelines and detailed requirements, regularly check the MDCO website or consult a regulatory expert.

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