Handling the Class III medical device MDACS registration in Hong Kong requires careful preparation, compliance with local regulations, and following a structured application process. Here’s a step-by-step guide on how to handle the MDACS registration for Class III medical devices:

1. Understand the Regulatory Requirements

Class III medical devices in Hong Kong are subject to the Medical Device Administrative Control System (MDACS), which is administered by the Department of Health (DoH). These devices are considered high-risk and require thorough scrutiny to ensure safety, efficacy, and quality.

Key Requirements:

• ISO 13485 Certification: The manufacturer must have ISO 13485 certification for the quality management system (QMS) in place.

• Clinical Data: Provide sufficient clinical data to prove the safety and efficacy of the device.

• Authorized Representative: If the manufacturer is based outside Hong Kong, an authorized representative must be appointed in Hong Kong to handle the registration process.

2. Prepare the Required Documentation

You need to compile a comprehensive set of documents to submit with your MDACS registration application. This typically includes:

Required Documents:

1. Application Form: Complete the MDACS application form, which includes device details, intended use, classification, and more.

2. ISO 13485 Certification: Provide a valid copy of your ISO 13485 certification or equivalent, proving that the manufacturer follows an internationally recognized quality management system.

3. Clinical Evaluation: Documentation of the clinical evaluation, including clinical trials, studies, and post-market surveillance data if applicable.

4. Device Description: A detailed description of the device, including its design, intended use, and technical specifications.

5. Risk Management File: Provide risk analysis and risk management files to demonstrate that the device complies with safety standards (e.g., ISO 14971).

6. Labeling: Ensure that labeling, including the Instructions for Use (IFU), complies with regulatory requirements.

7. Manufacturing Process Information: Documentation about the manufacturing processes, materials, and components used.

8. Post-Market Surveillance Plan: A plan to monitor the device after it enters the market, ensuring continuous safety and performance.

3. Submit the Application

After gathering the required documents, you can submit your application to the Department of Health through the MDACS online portal. Here’s how to handle the submission:

• Create an Account: Register an account on the MDACS online portal for the submission process.

• Fill Out the Application: Complete all necessary fields in the application form. Provide accurate details of the device, including the manufacturer and authorized representative (if applicable).

• Upload Documentation: Upload all required documents such as ISO certification, clinical data, technical files, and post-market surveillance plan.

• Payment of Fees: Pay any applicable registration fees as part of the application process.

4. Follow Up and Communication

Once the application is submitted, the Department of Health will conduct an initial review of the application and documentation. Here’s what to do next:

• Monitor the Application: Keep track of the application status through the MDACS online portal.

• Respond to Requests: If the DoH requests additional information or clarification, respond promptly to avoid delays in the approval process.

• Additional Information: Be prepared to provide further documentation or details if needed, especially regarding clinical data, risk management, or post-market surveillance.

5. Review Process

The DoH will conduct a thorough review of the application. The key stages include:

• Initial Review: The DoH will confirm that the application is complete and that all required documents are in place.

• Evaluation of Safety and Efficacy: For Class III devices, the DoH will evaluate clinical data and technical documentation to assess the safety and efficacy of the device.

• Request for Clarifications: If any issues are identified, the DoH will request additional information or clarifications.

• Decision: After completing the review, the DoH will make a decision on whether to approve or reject the application.

6. Registration Approval

If the application is successful, the DoH will issue a registration certificate for the Class III medical device. The registration certificate typically lasts for 5 years. Once registered:

• Ensure Ongoing Compliance: Adhere to all post-market surveillance and adverse event reporting requirements.

• Labeling and Advertising: Ensure that all device labeling and advertising comply with the regulatory standards.

• Annual Reports: Some devices require annual updates or reports to be submitted to the DoH.

7. Post-Registration Monitoring and Compliance

After obtaining registration, ongoing compliance with Hong Kong's medical device regulations is essential. Key post-registration requirements include:

• Adverse Event Reporting: If any adverse events occur post-market, they must be reported to the DoH within a specified timeframe (usually within 15 days for serious events).

• Post-Market Surveillance: You must implement a post-market surveillance system to monitor the device's performance and safety.

• Periodic Updates: Update the DoH with any significant changes to the device or its manufacturing process. Registration must be renewed every 5 years.

8. Renewal Process

After 5 years, the registration will expire, and a renewal application must be submitted to maintain the device’s legal status in Hong Kong.

Key Considerations:

• Timeliness: Ensure that all documents are prepared and submitted correctly to avoid delays in the review process.

• Local Representation: Appoint a reliable and knowledgeable authorized representative in Hong Kong if you are based outside of Hong Kong.

• Regulatory Changes: Stay informed about any updates to the Medical Device Administrative Control System (MDACS) and related regulations.

By following these steps and adhering to Hong Kong’s regulatory requirements, you can successfully handle the Class III medical device MDACS registration and ensure compliance throughout the device’s lifecycle.

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