To register and apply for Class I medical device MDACS registration in Hong Kong, you need to follow the steps outlined by the Department of Health (DH) under the Medical Device Administrative Control System (MDACS). The process ensures that the medical device complies with safety and performance requirements before being marketed in Hong Kong.

Here’s a step-by-step guide for registering and applying for Class I medical device MDACS registration in Hong Kong:

Steps for Registering and Applying for Class I Medical Device MDACS Registration in Hong Kong

Step 1: Determine the Classification of the Medical Device

• Class I Classification: Ensure your medical device is classified as Class I. Class I devices are low-risk devices and usually do not require pre-market approval but still need to comply with regulatory requirements.

  • Devices are self-declared by the manufacturer, provided they meet safety and performance standards.

  • Class I devices typically include non-invasive devices such as bandages, basic instruments, and devices that do not present significant risks.

Step 2: Appoint a Local Responsible Person (LRP)

• If your device is manufactured outside of Hong Kong, you must appoint a Local Responsible Person (LRP) based in Hong Kong.

  • The LRP acts as a liaison between the manufacturer and the Department of Health (DH) for regulatory matters and ensures compliance with Hong Kong's medical device regulations.

Step 3: Prepare the Required Documentation

Before you start the registration process, ensure that you have the following documents ready for submission:

• Application Form: Complete the online application form available on the MDACS portal.

• Device Description: Provide a clear and detailed description of the device, including its intended use, design, function, and specifications.

• Risk Management Documentation: Submit a risk management file that outlines the risk assessment for the device and the steps taken to mitigate any identified risks.

• Manufacturing Standards: If applicable, provide evidence that the device complies with ISO 13485 or other relevant quality standards.

• Clinical Evidence: Typically not required for Class I devices unless they present higher risks or the manufacturer is asked for additional documentation.

• Labeling and Instructions for Use (IFU): Submit the device's labeling and user manual. The labeling should include all necessary safety information, intended use, and usage instructions as required by Hong Kong regulations.

Step 4: Submit the Application Online via MDACS Portal

• Create an Account: Register for an account or log in to the MDACS portal (administered by the Department of Health).

• Fill in the Application Form: Provide the required details about your device, including the manufacturer, product information, and classification.

• Upload Documentation: Upload all the necessary documents (e.g., device description, risk management file, labeling, etc.) as per the application instructions.

• Pay the Registration Fee: After completing the application form and uploading documents, you will need to pay the registration fee. The fee structure can be found on the MDACS portal.

Step 5: DH Review of the Application

• The Department of Health (DH) will review your application and the accompanying documents.

  • The DH will assess the device for compliance with local safety and performance requirements.

  • Review Duration: The review process for Class I devices is generally quicker compared to higher-risk devices, but this may vary depending on the complexity of the device or additional requests for clarification.

Step 6: Approval and Issuance of Registration Certificate

• Once your application is reviewed and approved, the Department of Health will issue a registration certificate for your Class I medical device.

  • The registration certificate allows you to legally market and distribute your device in Hong Kong.

  • The certificate may be issued electronically or as a hard copy, depending on the DH’s process.

Step 7: Post-Market Obligations

• After the registration is approved, ensure that you continue to meet the post-market surveillance obligations. This includes:

  • Reporting any adverse events or issues related to the safety or performance of the device.

  • Ensuring that the device is monitored regularly for safety and quality once it is on the market.

  • Updating the DH on any changes to the device or its labeling.

Key Points to Note

1. Local Responsible Person (LRP) is required if the manufacturer is located outside Hong Kong.

2. Ensure your device complies with Hong Kong's safety and performance standards, which can be checked in the Medical Device Ordinance and the relevant guidelines.

3. The application process is generally online via the MDACS portal.

4. Class I devices can be self-declared, but still require registration.

5. Post-market surveillance obligations must be met once your device is approved and sold in Hong Kong.

By following these steps and submitting the required documentation, you can apply for Class I medical device MDACS registration in Hong Kong and ensure your device complies with local regulations.

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