To apply for Class I medical device MDACS registration in Hong Kong, you must follow a series of steps outlined by the Department of Health (DH). The MDACS (Medical Device Administrative Control System) registration process ensures that medical devices meet safety and performance standards before being sold in Hong Kong.

Here’s a step-by-step guide on how to apply:

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

1. Confirm Device Classification

• Verify Classification: Ensure that your device is classified as Class I under the MDACS system. Class I devices are typically low-risk devices and are subject to minimal regulatory control.

• Self-Declaration: In most cases, Class I devices can be self-declared as compliant with regulatory requirements, but it's essential to ensure that your device meets all the necessary criteria.

2. Create an Account on MDACS Portal

• Go to the Department of Health's MDACS official portal.

• Create an account or log in if you already have one. This portal is where you will submit your application for registration.

• Ensure that you have access to the necessary documentation and information before starting the online application.

3. Designate a Local Responsible Person (LRP) (if applicable)

• For non-Hong Kong manufacturers: If your device is manufactured outside of Hong Kong, you need to appoint a Local Responsible Person (LRP). This individual or entity will act as the liaison between the manufacturer and the Department of Health (DH).

4. Submit the Application Form

• Complete the online application form on the MDACS portal.

• Device Information: Provide detailed information about your Class I device, including its name, intended use, and manufacturer details.

• Classification: Confirm that the device is a Class I device.

• Device Description: Include a detailed description of the device, including its function, materials, and specifications.

5. Prepare and Submit Technical Documents

Submit the following required documents to the DH through the MDACS portal:

• Device Description: A clear and concise description of the device, including intended use and function.

• Risk Management File: A file that demonstrates a comprehensive risk assessment process to ensure that the device is safe and effective. This should include risk mitigation strategies.

• Labeling and Instructions for Use (IFU): The device’s labeling and user instructions must meet Hong Kong’s regulatory requirements. Ensure that they include language and information according to local standards.

• ISO 13485 Certification: If applicable, provide the ISO 13485 certificate, demonstrating that the manufacturing facility complies with international quality management standards.

• Clinical Evidence: If necessary, provide clinical data or evidence to support the safety and performance of the device (although this is typically not required for Class I devices unless there are specific risks).

6. Payment of Registration Fees

• After submitting the application form and necessary documents, you will be required to pay the registration fee.

• The fee structure can be found on the MDACS portal, and you will be notified of the payment procedure during the application process.

7. DH Review and Assessment

• The Department of Health will review your application and documents. This includes verifying that the device complies with local regulatory requirements.

• The DH may request additional documentation or clarification if there are any issues or gaps in your submission.

8. Receive Registration Certificate

• Once the DH completes the review and is satisfied with the application, they will issue a Class I medical device registration certificate.

• The device will then be legally allowed to be marketed and distributed in Hong Kong.

9. Post-Registration Requirements

• Once registered, you must comply with post-market surveillance requirements.

• Report any adverse events or issues related to the device's safety or performance.

• Ensure that the device continues to comply with any updates or changes in regulations issued by the Department of Health.

Key Things to Remember

• Local Responsible Person (LRP): If you are a foreign manufacturer, appointing an LRP is a crucial step.

• Compliance with Local Standards: Make sure your device and all associated materials (labeling, documentation, etc.) comply with Hong Kong's regulatory standards.

• Timely Submissions: Submit complete and accurate documentation to avoid delays in processing.

• Post-Market Monitoring: After registration, ensure ongoing compliance with Hong Kong’s safety and regulatory standards.

By following these steps and preparing the required materials thoroughly, you can navigate the MDACS registration process efficiently and ensure that your Class I medical device is successfully registered for use in Hong Kong.

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