Process, Required Documents, and Precautions 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 registering medical devices, including Class II devices, which are considered to have moderate risk. The Medical Device Control Office (MDCO), under the Hong Kong Department of Health, oversees the registration process.

Here’s a comprehensive guide on the process, required documents, and important precautions for applying for Class II MDACS registration in Hong Kong.

1. Process for Applying for Class II MDACS Registration

Step 1: Device Classification

• Ensure that your device is correctly classified as a Class II device under the MDACS classification criteria. If you're unsure, consult the Medical Device Classification Guidelines or seek professional advice.

Step 2: Appoint a Local Authorized Representative (If applicable)

• If the manufacturer is located outside Hong Kong, you must appoint a local authorized representative in Hong Kong. This representative will act as the point of contact with the Medical Device Control Office (MDCO) and will be responsible for submitting your registration application.

Step 3: Prepare Required Documentation

• Collect all necessary documents to demonstrate compliance with safety, performance, and regulatory standards. This will include technical documentation, labeling information, and risk management details (as outlined in the next section).

Step 4: Submit the Application

• Submit your application either online (through the MDACS platform) or by post (to the MDCO). You will need to provide all requested documentation along with the completed registration form.

Step 5: MDCO Review

• The MDCO will review the submitted application and documents. If the MDCO requires additional information or clarification, they will contact you. If everything is in order, the MDCO will approve the registration.

Step 6: Approval and Registration

• Upon successful review, the MDCO will register the Class II medical device and issue an official registration certificate.

Step 7: Post-Market Surveillance and Renewals

• Once the device is registered, you must comply with post-market surveillance regulations, such as reporting adverse events and keeping your device’s information up to date.

• MDACS registration is valid for 5 years, after which you must renew your registration.

2. Required Documents for Class II MDACS Registration

To apply for Class II medical device registration under MDACS, you must submit a comprehensive set of documents. These documents are used to demonstrate that your device is safe, effective, and compliant with Hong Kong's regulatory standards.

a. Application Form

• A completed MDACS registration application form, which can be downloaded from the Department of Health (DH) website or obtained from MDCO.

b. Manufacturer Information

• Manufacturer’s Details: The name, address, and contact information of the device manufacturer.

• Good Manufacturing Practice (GMP): Proof that the manufacturer complies with GMP requirements, such as a GMP certificate.

• Certificate of Free Sale: If the device is manufactured outside Hong Kong, a Certificate of Free Sale from the regulatory authority in the country of manufacture may be required. This certificate confirms that the device is legally sold in that country.

c. Device Information

• Product Description: A detailed description of the device, including its intended use, functionality, and clinical indications.

• Device Specifications: Information such as design, materials, and performance characteristics of the device.

• User Manual: A copy of the device’s user manual, including instructions for use, maintenance, safety precautions, and contraindications.

• Labeling: A sample of the product’s labeling, including product name, intended use, warnings, and instructions.

d. Compliance with International Standards

• Evidence of compliance with relevant international standards, such as:

  • ISO 13485 for quality management systems (for medical devices).

  • ISO 14971 for risk management (of medical devices).

  • ISO 10993 for biocompatibility (if applicable).

e. Risk Management Documentation

• Risk Assessment: Documentation showing that the risks associated with the device have been assessed and mitigated, as per ISO 14971.

f. Clinical Evaluation (if applicable)

• Depending on the type of Class II device, you may be required to provide clinical evaluation reports or clinical data to demonstrate the safety and effectiveness of the device.

g. Other Documents

• Any additional documents requested by the MDCO based on the type and complexity of the device (e.g., performance testing results, sterility validation, etc.).

3. Precautions and Tips for a Smooth Application Process

a. Verify Device Classification

• Double-check the device classification to ensure it falls under Class II. Misclassification could lead to delays or rejections. If in doubt, seek guidance from MDCO or a regulatory expert.

b. Ensure Documentation Completeness

• Complete all required documents before submitting the application. Incomplete or incorrect documentation is one of the main reasons for delays or rejections in the registration process.

c. Compliance with International Standards

• Ensure your device complies with ISO standards and provide the necessary certificates (e.g., ISO 13485, ISO 14971). The MDCO places significant importance on these standards.

d. Accurate Labeling

• Labeling is critical in the application process. Ensure that your device’s labeling complies with Hong Kong’s requirements, including the product name, manufacturer details, intended use, and safety warnings.

e. Appoint a Local Representative (if necessary)

• If the manufacturer is not based in Hong Kong, appoint a reliable local authorized representative. They must be based in Hong Kong and responsible for interacting with MDCO and other local authorities.

f. Monitor Processing Time

• MDCO reviews typically take 4 to 6 weeks, but this can vary depending on the completeness of your application and the workload of the MDCO. Make sure all documents are in order to avoid delays.

g. Keep Track of Post-Market Obligations

• Post-market surveillance is mandatory. You must report any adverse events or malfunctions associated with your device, and comply with any required renewals (every 5 years).

h. Update Device Information

• If there are any significant changes to the device (e.g., design, manufacturing process, or risk profile), notify the MDCO and update your registration.

Summary of Process and Precautions

• Process: Submit a completed application form, including all required documents such as product specifications, GMP compliance, risk management documentation, and clinical evaluation (if applicable).

• Documents: Manufacturer details, product description, ISO certifications, labeling, risk assessments, and clinical data (if needed).

• Precautions: Ensure correct classification, complete documentation, compliance with international standards, accurate labeling, and appoint a local representative (for foreign manufacturers).

By following these guidelines, you can ensure a smoother and more efficient registration process for your Class II medical device under MDACS in Hong Kong. If you need further assistance or have any questions, feel free to ask!

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