The processes for MDACS registration of Class III in vitro diagnostic medical devices (IVDs) in Hong Kong involve several structured steps. Below are the key processes, required materials, and precautions to consider:

Processes for MDACS Registration:

1. Determine Device Classification:

   • Confirm that your device qualifies as a Class III IVD based on intended use and risk assessment.

2. Prepare Documentation:

   • Compile a comprehensive technical file that includes:
     • Product Information: Description, intended use, and specifications.
     • Design and Manufacturing Information: Detailed manufacturing processes and quality control measures.
     • Quality Management System Documentation: Evidence of compliance with ISO 13485 or similar standards.
     • Clinical Data: Evidence of safety and efficacy from clinical trials or studies.
     • Labeling and Packaging Information: Labels must include all required information as per regulatory guidelines.
     • Risk Management Documentation: Risk assessment report identifying potential hazards and mitigation strategies.

3. Complete the Application Form:

   • Fill out the MDACS application form accurately with all required details.

4. Submit the Application:

   • Submit your application and accompanying documents to the Medical Device Control Office (MDCO) either online or by mail.

5. Pay the Registration Fee:

   • Include payment for the applicable registration fees as specified by the MDCO.

6. Review Process:

   • The MDCO will review the application. Be prepared to respond to any requests for additional information or clarification.

7. Approval and Registration:

   • Upon successful review, you will receive an MDACS registration certificate, allowing you to market your Class III IVD in Hong Kong.

8. Post-Market Surveillance:

   • Comply with ongoing regulatory obligations, including reporting adverse events and maintaining quality standards.

Required Materials:

• Completed Application Form: Accurately filled out and signed.
• Technical Documentation: Comprehensive information covering all aspects of the device.
• Quality Management System Evidence: ISO 13485 certification or equivalent.
• Clinical Data: Relevant studies and evidence supporting safety and efficacy.
• Risk Management Plan: Documentation outlining potential risks and management strategies.
• Labeling and Packaging Samples: Examples of how the device will be presented to users.
• Payment Receipt: Proof of payment for application fees.

Precautions to Consider:

• Thorough Documentation: Ensure that all documents are complete and accurately reflect the device's specifications and compliance.
• Regulatory Compliance: Stay updated on any changes to the regulations or requirements by regularly checking the MDCO website.
• Clear Communication: Maintain clear communication with the MDCO during the review process, responding promptly to any requests for additional information.
• Quality Assurance: Implement robust quality assurance practices throughout the development and submission processes.
• Consider Expert Guidance: If necessary, seek assistance from regulatory consultants who are familiar with the MDACS registration process.

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