To register a Class II medical device under the MDACS (Medical Device Administrative Control System) in Hong Kong, you must follow a series of steps to ensure compliance with local regulations and requirements. Here's a clear breakdown of the registration process:

1. Determine Device Classification

• Identify Device Class: Ensure your device qualifies as Class II, which generally includes devices with moderate risk, such as diagnostic tools or therapeutic devices.

• Class II devices are subject to MDACS registration in Hong Kong, and they require documentation to prove safety, efficacy, and quality.

2. Appoint a Local Authorized Representative (AR)

• For Foreign Manufacturers: If your company is based outside Hong Kong, you must appoint a local authorized representative (AR) in Hong Kong to manage the registration process on your behalf.

• The AR will act as the liaison with the Medical Device Control Office (MDCO) of the Hong Kong Department of Health.

• The AR’s Responsibilities: Includes submitting the application, ensuring regulatory compliance, and addressing any post-market concerns.

3. Prepare Required Documentation

The application for Class II MDACS registration requires a comprehensive set of documents to ensure your device meets regulatory requirements. These documents include:

1. Registration Application Form:

   • Complete the official MDACS registration form for Class II devices. This form will request information such as the device’s name, intended use, and manufacturer details.

2. Technical Documentation:

   • Device Description: Provide detailed information about the device, including its intended purpose, design, and components.

   • Risk Management: Include a Risk Management File (e.g., in compliance with ISO 14971).

   • Manufacturing Details: Include evidence that the manufacturer complies with Good Manufacturing Practices (GMP) or provides ISO 13485 certification.

   • Clinical/Performance Data: If applicable, provide data demonstrating the safety and effectiveness of the device.

   • Labeling: Provide a sample of the device’s labeling, which must meet the local regulatory requirements in terms of language, content, and safety information.

   • Declaration of Conformity: A statement confirming that the device complies with applicable international standards (e.g., CE marking or FDA approval).

3. Authorized Representative Documentation:

   • If using an AR, include a signed appointment letter outlining the responsibilities of the AR.

4. Other Certificates:

   • If applicable, include additional certificates such as CE, FDA, or ISO certifications, showing that the device complies with international safety and quality standards.

4. Submit the Application

• Online Application: The MDCO may have an online platform where you can submit your application electronically. If available, this is often the preferred method of submission.

• Paper Submission: If the MDCO requires paper submission, send the completed form and documents to the relevant department (usually the Department of Health).

Ensure all required documents are included in the application package to avoid delays or requests for additional information.

5. Review and Evaluation by MDCO

• The MDCO will review the submitted documentation to assess whether the device complies with the safety and performance requirements.

• Initial Review: The MDCO will check if all documents are complete and properly submitted.

• Evaluation: The MDCO will evaluate the device’s technical data, clinical performance, risk management documentation, and quality control measures.

• Clarifications: The MDCO may request further information or clarification on specific points before proceeding.

6. Approval or Rejection

• Approval: If the MDCO is satisfied with the application, they will issue a registration certificate for the device. The device will then be officially registered and allowed to be marketed and distributed in Hong Kong.

• Registration Number: Upon approval, a unique registration number will be assigned to the device, which must appear on the product’s labeling and promotional materials.

• Rejection: If the MDCO finds any deficiencies, the application may be rejected or returned for further clarification. In such cases, the manufacturer or AR will need to address the concerns and resubmit the application.

7. Post-Approval Responsibilities

• Post-Market Surveillance: After the registration is granted, manufacturers are required to implement post-market surveillance systems. This includes monitoring the safety and performance of the device once it is available in the market.

• Adverse Event Reporting: Manufacturers must report any adverse events or safety issues to the MDCO. They are also required to take corrective actions when necessary.

8. Renewal and Periodic Updates

• Registration Validity: The registration is typically valid for five years. After this period, you will need to apply for renewal.

• Device Changes: If there are any significant changes to the device (e.g., design changes, updates to labeling), these must be reported to the MDCO.

9. Monitoring and Compliance

• Ongoing Compliance: Ensure that your device continues to meet the regulatory standards and that your company adheres to ISO 13485 or other quality management systems.

• Stay Updated: Regularly monitor updates from the MDCO regarding any changes in regulations or requirements for medical devices in Hong Kong.

Summary of Steps:

1. Classify the Device: Ensure your device is classified as Class II.

2. Appoint an Authorized Representative (if you are a foreign manufacturer).

3. Prepare the Required Documentation: Gather all necessary documents, including device descriptions, clinical data, risk assessments, and labeling.

4. Submit the Application: Submit the completed application to the MDCO (via online or paper submission).

5. MDCO Review: Wait for the MDCO to evaluate and review your application.

6. Approval: If approved, receive a registration certificate and a unique registration number for your device.

7. Post-Market Surveillance: Maintain a surveillance system to track device safety and performance after market release.

8. Renewal: Apply for renewal every five years or whenever there are significant changes to the device.

By following these steps, you can successfully complete the Class II MDACS registration process and ensure your device complies with Hong Kong’s regulatory requirements.

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