To apply for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you will need to follow a structured process to ensure that all necessary documentation is submitted and that the device meets the regulatory requirements. Below are the detailed steps on how to apply for Class IV medical device registration under MDACS:

1. Determine Device Classification

Before applying, ensure that your device is correctly classified as Class IV under the MDACS system. Class IV devices are high-risk devices that require the most extensive regulatory documentation. These devices include implantable devices, life-supporting devices, and others that may pose significant risks to patient safety.

2. Prepare Required Documentation

For Class IV medical devices, a comprehensive set of documentation is required to ensure compliance with safety, performance, and regulatory standards. The required documents generally include:

Technical Documentation:

• Device Description: Provide a detailed description of the device, its intended use, and the target patient population.

• Risk Management: A comprehensive risk management report, including a risk assessment (ISO 14971).

• Clinical Data: Clinical evaluation reports or data demonstrating the device’s safety and effectiveness (e.g., clinical trials, literature review).

• Performance and Safety Testing: Results of performance testing, biocompatibility testing (ISO 10993), electrical safety tests (IEC 60601-1 for active devices), and other relevant testing based on the type of device.

• Manufacturing Information: Manufacturing process description and Good Manufacturing Practice (GMP) compliance.

• Instructions for Use (IFU) and Labeling: A copy of the device’s labeling and instructions for use that comply with MDACS requirements.

Quality Management System (QMS):

• ISO 13485: Proof of certification of your Quality Management System, which ensures that the device is designed, manufactured, and tested under stringent quality controls.

Certificates and Approvals:

• Certificate of Free Sale: Evidence that the device is marketed in another country with an approved regulatory framework (e.g., CE marking or FDA approval).

• Declaration of Conformity: A declaration from the manufacturer that the device complies with applicable standards and regulations.

Post-market Surveillance (if applicable):

• Post-market surveillance plan and procedures for reporting adverse events, device recalls, and continuous safety monitoring after the device reaches the market.

3. Choose an Authorized Representative (if applicable)

If the manufacturer is located outside Hong Kong, an authorized representative in Hong Kong is required. The authorized representative will handle the registration process on behalf of the manufacturer and be the point of contact with the Hong Kong Department of Health.

4. Submit the Application

The application for Class IV medical device registration must be submitted to the Hong Kong Department of Health (DH). Follow these steps:

Application Submission:

• Access the MDACS portal on the Hong Kong Department of Health’s website.

• Complete the medical device registration application form. This form will ask for device information, manufacturer details, and authorized representative details (if applicable).

• Attach the required documents (technical documentation, clinical data, ISO certifications, etc.) to the application.

Payment of Fees:

• Pay the applicable registration fees. Fees for Class IV devices are higher than those for lower-class devices, given the higher regulatory requirements.

5. Application Evaluation and Review

Once the application is submitted, the Hong Kong Department of Health will review the application. This process includes:

• Technical Evaluation: Reviewing the technical documentation, clinical data, performance testing, and risk management reports to ensure that the device meets safety and effectiveness requirements.

• Inspection (if applicable): The Department of Health may require an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP).

• Request for Additional Information: If there are any gaps or questions about the application, the Department of Health may request further documentation or clarification from the applicant.

6. Approval and Registration

If the application meets all the regulatory requirements, the Hong Kong Department of Health will issue a medical device registration certificate for the Class IV device. The device will be approved for sale and distribution in Hong Kong.

7. Post-Approval Requirements

After the device has been registered:

• Post-Market Surveillance: Continue to monitor the device’s safety and effectiveness on the market. Report any adverse events or device recalls to the Department of Health as part of the ongoing regulatory requirements.

• Renewal of Registration: Class IV medical device registrations are valid for 5 years. You will need to submit a renewal application before the registration expires to continue marketing the device in Hong Kong.

Summary of Steps to Apply for Class IV Medical Device Registration Under MDACS:

1. Determine Device Classification: Verify the device is classified as Class IV.

2. Prepare Required Documentation: Gather technical documentation, clinical data, performance tests, and certification documents.

3. Choose Authorized Representative: If the manufacturer is outside Hong Kong, appoint a local authorized representative.

4. Submit Application: Submit the application and required documents to the Hong Kong Department of Health via the MDACS portal, and pay the application fees.

5. Evaluation and Review: The Department of Health will evaluate the application and may request additional information or conduct inspections.

6. Approval and Registration: If the device meets the requirements, the registration certificate will be issued.

7. Post-Approval Requirements: Ensure post-market surveillance and comply with renewal processes every 5 years.

By following these steps, you can successfully apply for Class IV medical device registration under Hong Kong MDACS and ensure that your device is compliant with the regulatory requirements for market access.

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