Process and Steps for Class II Medical Device MDACS Registration in Hong Kong

The Medical Device Administrative Control System (MDACS) in Hong Kong is a voluntary regulatory framework for medical devices. Class II medical devices are those with a moderate risk to users and typically include devices like diagnostic equipment, certain therapeutic devices, or devices used in medical procedures. Here’s a step-by-step guide to applying for MDACS registration for a Class II medical device in Hong Kong:

Step 1: Classify the Device

• Classify your device to ensure it falls under Class II. The classification is based on the device’s intended use and risk to the patient. Class II devices generally pose moderate risks, such as non-invasive devices that require professional oversight.

  • To confirm your device’s classification, refer to the Medical Device Classification Guidelines issued by the Hong Kong Department of Health (DH).

  • If you're unsure about the classification, consider consulting the MDCO or a regulatory expert.

Step 2: Prepare Required Documentation

Prepare and organize the necessary documents for submission. For Class II medical devices, typical documentation includes:

a. General Application Form

• Complete the official MDACS registration form, which can be found on the Department of Health website or requested from the MDCO.

b. Manufacturer Information

• Company Details: Information about the manufacturer, including name, address, and contact details.

• Good Manufacturing Practice (GMP) Certificate: Provide evidence of compliance with GMP, if applicable.

• Certificate of Free Sale (if applicable): If the device is manufactured outside Hong Kong, you need a Certificate of Free Sale from the country of origin.

c. Product Information

• Device Description: Provide a detailed description of the device, including its intended use and clinical indications.

• Technical Specifications: Include device design, materials, components, and manufacturing processes.

• User Manual: Provide the user manual with clear instructions for use, maintenance, and safety.

• Device Labeling: Include sample labeling that complies with Hong Kong regulations (e.g., product name, indications, instructions for use, etc.).

d. Compliance with International Standards

• Provide evidence of compliance with international standards such as:

  • ISO 13485 for quality management systems

  • ISO 14971 for risk management of medical devices

  • ISO 10993 for biocompatibility testing, if applicable.

e. Clinical Data (if applicable)

• Depending on the device, clinical data may be required to demonstrate safety and performance. This could include clinical trials, case studies, or scientific literature supporting the device's efficacy.

f. Risk Assessment

• A risk analysis showing that the device has been assessed for safety and efficacy, including a risk management file in accordance with ISO 14971.

Step 3: Submit the Application

Once the required documents are prepared, submit your Class II medical device registration application to the Hong Kong Department of Health (DH) via the MDACS platform or directly to MDCO.

Submission Methods:

• Online Submission: Use the MDACS online portal if available, or

• Postal Submission: Submit the application documents physically to the Department of Health’s Medical Device Control Office.

You must ensure that the application is complete and accurate to avoid delays or additional requests for information.

Step 4: MDCO Review

The Medical Device Control Office (MDCO) will review the submitted application and supporting documents. This includes checking for compliance with regulatory standards, confirming the device classification, and verifying the safety and performance data.

Review Process:

• Initial Evaluation: MDCO will assess the documentation for completeness and compliance.

• Additional Information: MDCO may request additional clarification or documents during the review process.

• Duration: This review process can take several weeks to months, depending on the complexity of the device and the quality of the application.

Step 5: Registration Approval

Once MDCO completes the review and confirms that all requirements are met, your device will be registered under MDACS.

Outcome:

• You will receive a registration certificate from MDCO.

• The device will be listed in the MDACS database and can be marketed and sold in Hong Kong.

Step 6: Post-market Surveillance and Compliance

After the registration, the device is subject to ongoing monitoring and post-market surveillance. You will be required to report any adverse events, product defects, or recalls related to your device.

Post-Market Responsibilities:

• Adverse Event Reporting: If any issues with the device arise, you must report them to MDCO.

• Periodic Updates: Keep the MDCO informed of any changes to the device, such as updates to the labeling or modifications to the design.

• Renewals: MDACS registration is typically valid for five years, after which renewal is required. MDCO may conduct periodic audits to ensure continued compliance.

Key Considerations for MDACS Registration:

• Fees: The application will require payment of registration fees, which can be found on the MDCO’s website.

• Authorized Representative: If your company is based outside Hong Kong, you must appoint a local authorized representative who will handle communications with MDCO and ensure compliance with local regulations.

• Local Requirements: Make sure all documents are submitted in English or Chinese as required by the Department of Health.

Additional Resources:

For more detailed information and to access the registration forms and guidelines, you can visit the official website of the Hong Kong Department of Health’s MDCO:

• MDCO Guidelines and Application Forms: Hong Kong Department of Health - Medical Devices

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn