To apply for Class I medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you need to follow specific processes, prepare certain materials, and be mindful of key precautions to ensure a smooth application.

1. Registration Process

Step 1: Device Classification

• Confirm that your medical device is classified as Class I. These devices are generally low-risk and non-invasive, such as simple diagnostic tools or basic medical equipment.

• You can classify your device using the classification criteria outlined in Technical Reference TR-003.

Step 2: Appoint a Local Responsible Person (LRP)

• If you are an overseas manufacturer, you must appoint a Local Responsible Person (LRP) in Hong Kong. The LRP is responsible for submitting the registration and ensuring that the device complies with the MDACS requirements.

Step 3: Create an Account on the MDIS Portal

• Visit the Medical Device Information System (MDIS) portal to create an account.

  • MDIS Portal: MDIS Registration Portal

• All applications must be submitted online via this portal.

Step 4: Submit the Application

• Complete the online application form on the MDIS portal and upload the required materials (see below).

• Pay any applicable registration fees (though registration for Class I devices is typically fee-free).

Step 5: Review and Confirmation

• The Medical Device Division (MDD) will review the application, which typically takes around 12 weeks if all documentation is in order.

• If your device is compliant, the MDD will approve the listing of your device under MDACS.

2. Required Materials

A. Device Description

• Basic details about the device, including:

  • Name of the device.

  • Intended use and indications.

  • Device model, version, or configuration (if applicable).

  • Manufacturer and responsible entity details.

B. Conformity Evidence

• Conformity to Safety and Performance Standards:

  • A Declaration of Conformity to international standards (e.g., ISO 13485, ISO 14971, or similar).

  • If available, proof of approval from other regulatory bodies (e.g., CE mark or FDA clearance).

C. Labeling Information

• Product Labeling: Provide information related to the labeling and packaging, including:

  • Name and address of the manufacturer or distributor.

  • Instructions for use, any warnings, and usage guidelines.

  • Safety information and symbols (if applicable).

D. Risk Assessment

• For Class I devices, the risk is typically minimal, but a basic risk assessment should still be included. This helps justify the device's classification as Class I and ensures safety for users.

E. Manufacturing Information

• Details regarding the manufacturing process and quality control procedures.

F. Local Responsible Person (LRP) Details

• If you are an overseas manufacturer, provide the LRP's contact information, including their registration with MDACS.

3. Precautions to Keep in Mind

A. Accuracy of Information

• Ensure that all submitted information is complete and accurate to avoid delays in processing.

• This includes device specifications, manufacturing processes, risk assessments, and labeling details.

B. Local Responsible Person Requirement

• If you are an overseas manufacturer, appoint a qualified LRP. They must be based in Hong Kong and are responsible for ensuring that your device complies with MDACS regulations. Failure to have a local representative could delay or prevent your application from being processed.

C. Online Submission

• The MDIS platform is fully online. Ensure you have all necessary documents in digital format before submission to avoid delays.

D. Review Timeline

• MDACS typically takes up to 12 weeks to process Class I applications. Be mindful of this time frame and ensure that your application is submitted well in advance of your intended market launch.

E. Post-Market Surveillance

• Even after your device is listed under MDACS, you must comply with post-market surveillance requirements, including:

  • Reporting adverse events and product recalls, if applicable.

  • Updating device information (e.g., changes in manufacturer, labeling, or performance).

F. Stay Updated

• Regulatory requirements may change over time. Always check the MDACS website or consult with a local Local Responsible Person (LRP) to stay informed about the latest updates to registration procedures and requirements.

4. Additional Considerations

• Hong Kong Regulatory Environment: While MDACS is voluntary, it provides a way to demonstrate that your device meets local safety and regulatory standards, which is crucial for market entry and consumer confidence.

• Compliance with International Standards: Even though registration is relatively straightforward for Class I devices, ensuring that your device complies with international medical device standards (like ISO 13485 or IEC 60601) will make the registration process smoother.

Conclusion

Registering a Class I medical device under MDACS is a relatively simple and straightforward process, especially compared to higher-risk devices. However, attention to detail in terms of documentation, classification, and compliance with local requirements (such as appointing a Local Responsible Person) is crucial for a successful application.

For more information, visit the official MDACS page: MDACS Registration.

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