To register and apply for Class III medical device MDACS registration in Hong Kong, you must follow a well-structured process governed by the Department of Health (DoH) under the Medical Device Administrative Control System (MDACS). Here’s a step-by-step guide to help you navigate the process:

Step 1: Determine if Your Device is Class III

Class III medical devices are considered high-risk devices that require detailed evaluation before they can be marketed in Hong Kong. These devices typically include implantable devices, life-sustaining devices, and those where failure could lead to significant harm.

• Examples of Class III devices: Heart pacemakers, large-volume infusion pumps, implantable prostheses, etc.

You need to verify that your device qualifies as a Class III medical device under Hong Kong regulations.

Step 2: Appoint an Authorized Representative (If Applicable)

If your company is based outside Hong Kong, you will need to appoint an Authorized Representative based in Hong Kong. This representative will handle the registration process on your behalf and serve as a point of contact with the Department of Health (DoH).

The authorized representative should be familiar with the regulatory framework for medical devices in Hong Kong and will be responsible for managing communication and ensuring the submission is complete.

Step 3: Prepare the Required Documentation

Before submitting your application, ensure you have gathered all necessary documents. For Class III medical device registration, the following documents are typically required:

Required Documentation:

1. MDACS Application Form: Complete the application form with detailed information about the device, its intended use, and its manufacturer.

2. ISO 13485 Certificate: Provide evidence that the manufacturer follows ISO 13485, which outlines the requirements for a Quality Management System (QMS) for medical devices.

3. Clinical Evaluation Report: Submit clinical data and evidence that the device is safe and effective. This could include clinical trials, research studies, or post-market surveillance data.

4. Device Description: Include detailed information about the device, such as its design, function, intended use, and any relevant technical specifications.

5. Risk Management File: Provide documentation that demonstrates compliance with ISO 14971 for risk management in medical devices.

6. Manufacturing Information: Information about the manufacturer’s processes, quality control, and materials used in production.

7. Labeling and Instructions for Use (IFU): Submit the proposed device labels and instructions for use, ensuring that they comply with Hong Kong’s medical device labeling standards.

8. Post-Market Surveillance Plan: A plan outlining how the device will be monitored after it is placed on the market to ensure continuous safety and performance.

Step 4: Create an Account and Submit the Application

Once the documentation is complete, you can submit your application to the Department of Health (DoH) through the MDACS online portal. Here’s how you can proceed:

1. Register for an Account: Create an account on the MDACS online portal. This portal will allow you to submit your application, track the status, and receive communications from the DoH.

2. Fill Out the Application Form: Complete the MDACS registration application form. Provide all required information such as the device’s classification, manufacturer details, authorized representative details, and device-specific information.

3. Upload Required Documents: Upload all the necessary documents, such as ISO 13485 certification, clinical evaluation reports, risk management files, and post-market surveillance plans.

4. Pay Registration Fees: Pay the applicable registration fees. These fees will vary depending on the class of the device and other factors, and they are generally paid through the online portal.

Step 5: Wait for the Review and Approval

Once your application is submitted, the Department of Health (DoH) will begin the review process. This involves the following stages:

1. Initial Review: The DoH will confirm that the application is complete and that all required documents have been submitted.

2. Evaluation of Safety and Efficacy: The DoH will review the clinical evaluation and technical documentation to assess the safety, efficacy, and risk management associated with the device.

3. Requests for Clarification (if necessary): If the DoH requires additional information, they will request clarification or further documentation. Respond promptly to avoid delays.

4. Final Decision: The DoH will make a final decision regarding the registration. If the application is approved, they will issue a registration certificate for the Class III device.

Step 6: Post-Approval Compliance

After your device is approved and registered by the DoH, you must comply with ongoing regulatory requirements, including:

• Post-Market Surveillance: Monitor the device’s performance and safety on the market. This includes tracking any adverse events or failures and reporting them to the DoH as required.

• Adverse Event Reporting: Any serious incidents involving the device must be reported to the DoH within 15 days of becoming aware of them.

• Periodic Updates: Submit regular updates to the DoH as required, especially if there are any changes to the device’s labeling, safety, performance, or manufacturing processes.

Step 7: Device Registration Renewal

Class III medical device registrations are typically valid for 5 years. You must apply for renewal before the expiration date to maintain the device’s registration. The renewal application may require updated documentation or additional information.

Additional Considerations:

• Ensure Documentation is Complete: Missing or incomplete documents can lead to delays or rejection. Double-check all documents before submitting.

• Local Authorized Representative: If you are an overseas manufacturer, appointing a reliable authorized representative in Hong Kong is crucial for navigating the process smoothly.

• Timely Responses: If the DoH requests additional information or clarification, respond as quickly as possible to avoid unnecessary delays.

• Regulatory Updates: Keep track of any changes to MDACS regulations to ensure your device remains compliant throughout its lifecycle.

By following these steps and ensuring compliance with all regulatory requirements, you can successfully register your Class III medical device under the MDACS in Hong Kong.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn