To apply for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong, certain conditions and requirements must be met. These conditions ensure that the device is safe, effective, and compliant with local regulations. Here’s a detailed overview of the conditions that must be fulfilled:

Conditions for MDACS Registration

1. Device Classification:

   • Ensure that your device is correctly classified as Class IV. This classification is generally reserved for high-risk IVD devices that can have a significant impact on patient safety and health.

2. Compliance with Regulatory Framework:

   • Adhere to the relevant regulations as outlined in the Medical Device Ordinance (Cap. 663) and associated guidelines. This includes understanding the specific requirements for Class IV devices.

3. Quality Management System (QMS):

   • Implement a documented quality management system that complies with ISO 13485 or equivalent standards. The QMS should cover all aspects of design, manufacturing, and post-market activities.

4. Technical Documentation:

   • Prepare comprehensive technical documentation that demonstrates the device’s design, manufacturing process, intended use, and performance characteristics. This should include:
     • Device description.
     • Design and manufacturing information.
     • Performance data and validation studies.
     • Risk analysis as per ISO 14971, identifying potential hazards and risk control measures.

5. Clinical Evidence:

   • Provide robust clinical evidence supporting the safety and effectiveness of the device. This may include:
     • Results from clinical trials or studies.
     • Data from similar or predicate devices.
     • Relevant literature reviews.

6. Labeling and Instructions for Use:

   • Ensure that product labeling, packaging, and instructions for use (IFU) are clear, accurate, and compliant with regulatory requirements. Labels should include necessary warnings and instructions to ensure safe use.

7. Manufacturer Information:

   • Provide detailed information about the manufacturer, including:
     • Name and address.
     • Regulatory status in the country of origin.
     • Information about any authorized representatives in Hong Kong.

8. Financial Viability:

   • Demonstrate the financial capability to support the ongoing compliance with regulatory requirements, including post-market surveillance and reporting obligations.

9. Post-Market Surveillance Plan:

   • Outline a post-market surveillance strategy that describes how you will monitor the safety and performance of the device once it is on the market. This includes procedures for reporting adverse events and handling complaints.

Key Considerations

• Regulatory Knowledge: Ensure you have a thorough understanding of the regulatory landscape for medical devices in Hong Kong, especially for Class IV IVDs.
• Thorough Documentation: The success of your application largely depends on the completeness and accuracy of your documentation. Take the time to prepare comprehensive and well-organized application materials.
• Collaboration: Involve relevant departments (e.g., R&D, regulatory affairs, quality assurance) to ensure that all aspects of the device and its documentation are adequately addressed.
• Consultation: Consider seeking guidance from regulatory consultants or legal professionals with expertise in Hong Kong's medical device regulations to assist with the application process.

By meeting these conditions, you can facilitate the MDACS registration process for your Class IV in vitro diagnostic medical device in Hong Kong.

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