To apply for Class IV medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), you must follow a structured application process. Class IV devices are the highest risk category and include products like implantable devices, life-supporting devices, and certain diagnostic devices. Below are the detailed steps you need to take:

Step 1: Confirm Device Classification

The first step in the application process is confirming that your device is classified as Class IV under the MDACS classification system. This step is crucial because the regulatory requirements for medical device registration vary based on the classification of the device.

• Action: Review the MDACS classification guidelines or consult with a regulatory expert to ensure your device is correctly classified. Class IV devices are considered high-risk and require a comprehensive application process.

Step 2: Prepare the Required Documentation

Class IV medical devices must be accompanied by extensive technical documentation that demonstrates the device's safety, performance, and compliance with relevant standards. The following documents are typically required for Class IV device registration:

1. Device Description: A detailed description of the device, including its intended use, design, and technological characteristics.

2. Clinical Evaluation Report (CER): A clinical evaluation report that reviews the safety and performance of the device based on clinical data or studies.

3. Risk Management Documentation: A report based on ISO 14971 standards, detailing the device’s risk analysis and management plan to ensure patient safety.

4. Quality Management System (QMS) Certification: A copy of the ISO 13485 certification (or equivalent) that shows compliance with quality management standards for medical devices.

5. Manufacturing Information: Information regarding the manufacturing processes, facilities, and controls used during production.

6. Labeling and Instructions for Use (IFU): A copy of the device’s labeling and user instructions, which must meet the MDACS labeling requirements.

7. Performance and Testing Data: Data from preclinical and clinical tests that demonstrate the device’s safety and efficacy.

8. Declaration of Conformity: If applicable, proof of compliance with other international regulatory requirements (e.g., CE Marking, FDA approval).

These documents must be complete and accurate. They should be submitted in English or Chinese; if not, translations must be provided.

Step 3: Submit the Application

Once you have gathered all the required documentation, you will need to submit your application to the Hong Kong Department of Health (DH). The submission process typically occurs through the MDACS Online System.

1. Complete the Application Form: The application form requires details about the device, the manufacturer, and its intended use.

2. Upload Supporting Documents: All supporting documents (e.g., clinical data, QMS certification, risk management) must be uploaded alongside the application form.

3. Pay the Application Fee: You will need to pay the prescribed application fee, which varies based on the device’s classification and the complexity of the review process. The fee for Class IV devices is typically higher than for lower-risk devices.

Step 4: Review by Hong Kong Department of Health

Once the application has been submitted, the Hong Kong Department of Health (DH) will begin reviewing the application. The DH will conduct a thorough assessment to ensure that the device complies with the regulatory requirements and that it meets the safety and efficacy standards.

1. Document Review: The DH will review all the submitted documents to ensure completeness and compliance with regulatory standards.

2. Clinical Data Review: For Class IV devices, the DH will scrutinize the clinical evaluation report and any supporting clinical data to verify the device’s safety and performance.

3. Risk Management Review: The DH will review the risk management process in accordance with ISO 14971 to ensure all potential risks associated with the device have been adequately addressed.

4. Inspection and Audits: In some cases, the DH may require on-site inspections of the manufacturing facility or audits of the manufacturer’s quality management system.

The review process may take between 2 to 6 months, depending on the complexity of the device and the completeness of the submitted documentation.

Step 5: Address Additional Information Requests (If Any)

If the DH requires additional information or clarification regarding your application, they will notify you. This might include requests for further clinical data, clarification on labeling or instructions for use, or additional risk management information.

It is important to respond promptly to any requests from the DH to avoid delays in the review process.

Step 6: Issuance of Registration Certificate

If the DH is satisfied with the application and all supporting documentation, they will issue a registration certificate for the Class IV device. This certificate allows the device to be marketed and sold in Hong Kong.

• Validity: The registration certificate is valid for 5 years. After 5 years, the manufacturer must submit a renewal application to continue marketing the device in Hong Kong.

Step 7: Post-Market Surveillance and Compliance

After the device is registered, manufacturers are required to adhere to post-market obligations, including:

• Adverse Event Reporting: Manufacturers must report any adverse events, incidents, or safety concerns associated with the device to the Hong Kong Department of Health.

• Market Surveillance: Ongoing monitoring of the device's performance in the market is required to ensure it remains safe and effective.

• Recall and Corrective Actions: If any safety issues arise, manufacturers may be required to recall the device or take corrective actions.

Step 8: Renewal of Registration

The registration certificate for Class IV devices is valid for 5 years. To continue marketing the device, manufacturers must apply for renewal before the certificate expires. The renewal process involves submitting updated documentation, such as post-market data, clinical performance information, and any changes to the device’s labeling or manufacturing process.

Where to Apply

• The application for Class IV medical device registration under MDACS should be submitted through the Hong Kong Department of Health.

• The submission can be done online via the MDACS Online System.

Key Considerations for Application

• Thorough Documentation: Ensure that all required documents are complete, accurate, and in compliance with regulatory standards.

• Clinical Data: A robust clinical evaluation is crucial for Class IV devices. The clinical data must support the safety and effectiveness of the device.

• Timely Communication: Respond quickly and thoroughly to any requests for additional information or clarifications from the Department of Health.

• Post-Market Obligations: Prepare for post-market surveillance and compliance activities once the device is registered.

Conclusion

The process for applying for Class IV medical device registration under Hong Kong MDACS involves several key steps: confirming device classification, preparing detailed technical documentation, submitting the application to the Hong Kong Department of Health, and undergoing a thorough review process. By adhering to the required steps and maintaining compliance with the regulations, manufacturers can successfully register their Class IV devices in Hong Kong.

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