Requirements for Applying for Class II Medical Device MDACS Registration in Hong Kong

The Medical Device Administrative Control System (MDACS) in Hong Kong is a voluntary system for medical device registration, aimed at ensuring the safety and effectiveness of medical devices available in the market. Class II devices, which are moderate-risk devices, must meet specific requirements for registration under this system. Here is a detailed list of the key requirements for applying for Class II medical device registration in Hong Kong:

1. Classification of the Device

• Confirm the classification of your medical device as Class II. Devices are classified based on their intended use and risk level, with Class II devices typically presenting moderate risk.

• To determine the classification, refer to the Medical Device Classification Guidelines provided by the Hong Kong Department of Health (DH). If you're unsure about the classification, you can seek guidance from the Medical Device Control Office (MDCO) or a regulatory consultant.

2. Documentation Requirements

To register a Class II medical device under MDACS, you will need to submit a comprehensive set of documents that demonstrate the safety, performance, and quality of the device. These documents include:

a. Application Form

• Completed Registration Form: Submit the official MDACS registration form, which can be downloaded from the Department of Health’s website or obtained directly from MDCO.

b. Manufacturer Information

• Company Details: Include the name, address, and contact details of the device manufacturer.

• Good Manufacturing Practice (GMP): Evidence of compliance with GMP, such as a GMP certificate from the manufacturer.

• Certificate of Free Sale: If the device is manufactured outside of Hong Kong, a Certificate of Free Sale issued by the regulatory authority of the country of origin may be required. This document proves that the device is legally sold in that country.

c. Product Information

• Device Description: A clear and detailed description of the device, including its intended use and any clinical indications. This should outline what the device is used for, how it is applied, and the patient population it serves.

• Device Specifications: Technical documentation that includes information such as:

  • Materials used in the device.

  • Design and manufacturing processes.

  • Functional and performance characteristics.

• User Manual: The device's user manual, which should include clear instructions for use, warnings, contraindications, and maintenance guidelines.

• Labeling: A sample of the labeling used on the device packaging, which should include essential information like the product name, intended use, directions for use, and warnings.

d. Compliance with International Standards

• ISO Certifications: Provide evidence of compliance with relevant international standards, including:

  • ISO 13485 for quality management systems for medical devices.

  • ISO 14971 for risk management of medical devices.

  • ISO 10993 for biocompatibility of materials (if applicable).

• If the device is a high-risk Class II device, clinical data or clinical evaluations may be required to demonstrate safety and effectiveness.

e. Risk Management

• Risk Assessment: Provide documentation demonstrating that the risks associated with the device have been evaluated and mitigated according to ISO 14971. This includes a risk management plan and a report detailing the risk analysis process for the device.

3. Local Authorized Representative

• If the device is manufactured outside Hong Kong, the manufacturer must appoint a local authorized representative in Hong Kong. The representative will act as the point of contact between the manufacturer and the Hong Kong Department of Health for regulatory matters.

• This representative is responsible for submitting the registration documents and ensuring compliance with local regulations.

4. Fees

• Registration Fee: The application for MDACS registration requires payment of a registration fee, which varies depending on the device class and other factors. Check the latest fee schedule on the Department of Health’s website or consult with MDCO for exact details.

5. Labeling and Instruction Requirements

• Device Labeling: The labeling on the device packaging must comply with Hong Kong regulations, and it should include:

  • The product name and model number.

  • The manufacturer’s name and contact information.

  • Intended use, directions for use, warnings, contraindications, and any other safety information.

• Language: The information on the labeling and instructions should be in English or Chinese, as required by the Hong Kong Department of Health.

6. Clinical Evaluation or Data (if applicable)

• Some Class II devices may require clinical evaluation or clinical data to demonstrate their safety and effectiveness.

  • Clinical Trials: If clinical trials are necessary, provide data showing that the device performs as intended and meets safety standards.

  • Scientific Literature: In some cases, supporting clinical data from existing literature may be sufficient, particularly for established devices with proven safety records.

7. Post-Market Surveillance Plan

• After registration, the device is subject to post-market surveillance. The manufacturer must report adverse events, product defects, and recalls to the Medical Device Control Office (MDCO).

• You may be required to monitor and report any issues related to the device's safety or performance once it is on the market.

8. Device Testing and Conformance

• Depending on the type of Class II device, certain tests may be required to demonstrate conformity with international standards. For example:

  • Biocompatibility tests (for devices that come into contact with the body).

  • Electrical safety tests (for powered devices).

  • Sterility validation (for sterile devices).

  • Performance testing (e.g., for diagnostic devices).

9. Application Submission

• Online Submission: You can submit the completed registration application online through the MDACS platform if available, or through the appropriate channels as instructed by MDCO.

• Postal Submission: If necessary, you may need to submit physical copies of the documentation to the Department of Health.

10. Registration Approval

• Once MDCO reviews your application and confirms that all the requirements are met, the device will be registered in the MDACS database.

• Upon approval, the device is allowed to be marketed in Hong Kong.

11. Ongoing Compliance

• Once the device is registered, manufacturers must comply with post-market surveillance regulations, including reporting any adverse events or device malfunctions.

• The registration is typically valid for five years, after which the device must be renewed.

Summary of Requirements for Class II MDACS Registration in Hong Kong:

• Device classification confirmation (Class II).

• Detailed product information, including labeling and technical specifications.

• Evidence of compliance with international standards (ISO 13485, ISO 14971, etc.).

• Risk management and clinical evaluation data (if applicable).

• Appointment of a local authorized representative (for foreign manufacturers).

• Registration fee payment.

• Post-market surveillance commitment.

For more specific guidance or to begin the process, you can visit the Hong Kong Department of Health website or reach out to MDCO for more detailed instructions and updates. Let me know if you need any further details or assistance!

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