The requirements for MDACS registration of Class III in vitro diagnostic medical devices in Hong Kong include:

1. Device Classification: Confirmation that the device is classified as Class III based on intended use and risk assessment.

2. Technical Documentation: Comprehensive technical file that includes:

   • Detailed product description and intended use.
   • Design and manufacturing processes.
   • Quality management system documentation (e.g., ISO 13485 certification).
   • Safety and effectiveness evidence, including clinical data and performance studies.

3. Labeling Information: Clear labeling and packaging details that comply with regulatory standards.

4. Risk Management: A risk assessment report that identifies potential hazards and mitigation strategies.

5. Application Form: Completed MDACS application form with accurate and complete information.

6. Fees: Payment of the applicable registration fees as specified by the Medical Device Control Office (MDCO).

7. Compliance with Regulations: Assurance that the device meets relevant safety and performance standards as required by Hong Kong regulations.

It’s essential to refer to the MDCO website for any updates or specific guidelines related to your device type.

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