To apply for Class A medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), the procedure involves several steps to ensure compliance with regulatory standards. Below is a detailed outline of the procedure to apply for Class A medical device registration in Hong Kong:

1. Classify the Medical Device

• Confirm Device Classification: Ensure that the device qualifies as Class A, which are considered low-risk medical devices. Class A devices are generally non-invasive, and the risks associated with their use are minimal. Check the MDACS classification guidelines to verify the classification of your device.

2. Prepare Required Documentation

For Class A medical device registration, the following documents must be prepared and submitted:

• Device Description: Detailed description of the device, including its intended use, features, and technical specifications.

• Risk Management Plan: Document addressing the risk assessment and risk management for the device (as per ISO 14971).

• Compliance with International Standards: Evidence that the device complies with relevant international standards (e.g., ISO 13485 for quality management systems and ISO 14971 for risk management).

• Labeling and Instructions for Use (IFU): A copy of the device labeling, including safety instructions, warnings, and intended usage. This must comply with Hong Kong's medical device labeling requirements.

• Declaration of Conformity: A formal statement from the manufacturer or authorized representative confirming that the device meets applicable regulatory standards.

• Market Authorization in Other Regions (if applicable): If the device is registered in other regions (e.g., the EU, USA), provide evidence of market approval in these jurisdictions.

• Post-Market Surveillance Plan: Outline how the device will be monitored once it is marketed, including reporting adverse events or recalls.

3. Submit the Application Online

• MDACS Portal: Applications for Class A medical devices must be submitted through the MDACS portal, operated by the Hong Kong Department of Health.

• Create an Account: If you don't already have an account, you will need to create one on the MDACS online platform.

• Fill Out the Application Form: Complete the application form available on the MDACS portal. You will need to provide:

  • Manufacturer's details (or authorized representative in Hong Kong if the manufacturer is based overseas).

  • Device classification and intended use.

  • All required supporting documents (such as technical documentation and compliance certificates).

• Upload Supporting Documents: Attach all the required documents in electronic format (e.g., PDFs) to the application.

4. Pay Registration Fees

• Fee Payment: Once the application is submitted, you will be required to pay the applicable registration fee. The fee amount will vary based on the device type and may be paid through the online MDACS system.

• Payment Confirmation: After payment, you will receive an invoice or confirmation for your payment.

5. Review and Evaluation

• Initial Screening: The Department of Health will conduct a preliminary review to ensure all necessary documents have been submitted and that the application is complete.

• Technical Evaluation: The device will undergo a detailed evaluation to verify that it meets safety, performance, and compliance standards. This includes checking the risk management documentation, quality management system (e.g., ISO 13485), and ensuring that the device complies with the relevant Hong Kong regulations.

• Additional Information: If the Department of Health identifies any issues or gaps in the submission, they may request additional documentation or clarification. Prompt responses will help avoid delays.

6. Registration Decision

• Approval or Rejection: Based on the evaluation, the Department of Health will either approve or reject the registration application. If the application is successful, you will receive a registration certificate for the device.

• Registration Number: The registration certificate will include a registration number, which is required for marketing and distributing the device in Hong Kong.

• Post-Approval Conditions: Once registered, the device may be subject to post-market surveillance and regulatory reporting requirements, including the monitoring of adverse events.

7. Post-Market Surveillance

• Compliance Monitoring: After the device is placed on the market, ensure that you comply with Hong Kong's post-market surveillance regulations. This includes:

  • Monitoring the performance of the device.

  • Reporting any adverse events or safety concerns to the Department of Health.

  • Adhering to any recall or corrective actions if needed.

• Regular Updates: Ensure that you keep the registration up to date, including any updates to the device or its labeling, and comply with periodic review requirements.

8. Periodic Updates or Renewal

• Depending on the regulatory requirements, Class A medical device registrations may need to be renewed or updated periodically. Be aware of the registration validity period and any necessary updates or renewals to maintain the device’s legal status in Hong Kong.

Summary of Steps:

1. Classify the Device: Confirm that it is a Class A device.

2. Prepare Documentation: Include device description, risk management, compliance certifications, labeling, and post-market surveillance plans.

3. Submit Application: Submit through the MDACS portal, filling out the required form and uploading the necessary documents.

4. Pay Fees: Pay the applicable registration fees online.

5. Review and Evaluation: The Department of Health evaluates the application, including technical documentation and compliance with regulations.

6. Registration Decision: Receive the registration certificate and registration number if the application is approved.

7. Post-Market Surveillance: Comply with post-market surveillance obligations and report adverse events as required.

8. Renewal or Updates: Track the registration period and submit periodic updates or renewals.

By following these steps carefully and ensuring your documentation is complete, you can successfully apply for Class A medical device registration under Hong Kong’s MDACS.

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