The process for Class III medical device MDACS registration in Hong Kong involves several key steps, including ensuring compliance with local regulations, preparing necessary documentation, submitting the application to the Department of Health (DoH), and undergoing review. Here’s a detailed breakdown of the process and steps for Class III medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong:

1. Preparation Phase: Gather Necessary Documentation

Before applying for MDACS registration, ensure that you have all the required documentation and meet the necessary criteria for your Class III medical device. The key steps in the preparation phase include:

• Determine Class III Device Status: Confirm that your device qualifies as a Class III medical device under Hong Kong regulations, which typically includes high-risk devices such as implantable devices or devices that require significant clinical evaluation.

• Establish a Local Authorized Representative (AR): If your company is based outside Hong Kong, you must appoint a Hong Kong-based authorized representative to submit the application and liaise with the Department of Health (DoH) on your behalf.

• Ensure ISO 13485 Certification: Ensure that your manufacturing facility holds ISO 13485 certification or equivalent quality management system certification. This is a crucial requirement for Class III medical devices.

• Clinical Data and Risk Management: Prepare clinical evaluation data, including clinical trials (if applicable), risk management files, and evidence of safety and efficacy.

• Technical Documentation: Gather technical documentation such as:

  • Device description

  • Intended use

  • Device labeling (IFU, packaging)

  • Risk management plan

  • Post-market surveillance plan

  • Manufacturing process documentation

2. Submit MDACS Registration Application

Once you have all necessary documents, you can proceed with the registration process.

• Create an Account on MDACS Online Portal: To submit the registration application, create an account on the MDACS online registration system provided by the Department of Health (DoH).

• Prepare the Application: Complete the MDACS registration form with detailed information about the device, including:

  • Device Name and Classification

  • Manufacturer and Authorized Representative (if applicable) details

  • Device Specifications and Indications for Use

• Submit the Application: Upload all required documents via the MDACS portal, including technical documentation, ISO 13485 certification, and clinical data. Ensure all details are accurate and complete to avoid delays.

3. Application Review

After submission, the Department of Health (DoH) will review your application. The review process typically involves the following:

• Initial Review: The DoH will check that the submitted documents are complete and meet regulatory requirements.

• Evaluation of Device Safety and Efficacy: For Class III devices, the DoH will assess the safety and efficacy data, clinical evaluation reports, and risk management documentation.

• Request for Additional Information: If the DoH finds any discrepancies or missing information, they will request further clarification or additional documentation.

• Post-Market Surveillance Plan Review: For high-risk devices like Class III, the DoH may review your post-market surveillance and vigilance procedures to ensure ongoing monitoring of the device’s safety.

4. Approval and Issuance of Registration

If the application is approved after the review process, the Department of Health will issue the official registration certificate for your Class III medical device.

• Issuance of Registration Certificate: Upon successful approval, you will receive an official registration certificate from the DoH, confirming that your Class III medical device is legally registered for sale in Hong Kong.

• Registration Validity: The registration is valid for a set period (usually up to 5 years). After this period, the device will need to be renewed for continued sale and distribution.

5. Post-Approval Requirements

Once your Class III medical device is registered, you must adhere to ongoing regulatory requirements, including:

• Labeling and Advertising Compliance: Ensure that your device labeling, advertising, and promotional materials comply with the regulations set forth by the DoH.

• Post-Market Surveillance: Implement and maintain post-market surveillance practices to monitor the device’s safety, including periodic reports and investigations into adverse events or complaints.

• Annual Reports: Some devices require annual updates or post-market safety reports to be submitted to the DoH.

• Adverse Event Reporting: Report any serious adverse events related to your device to the DoH within a specific timeframe (typically 15 days for serious events).

6. Periodic Updates and Renewals

Class III devices require periodic updates to maintain regulatory compliance. This includes:

• Renewing Registration: After the registration expires (usually after 5 years), you must submit a renewal application with updated documentation.

• Updating Technical Documentation: If there are significant changes to the device, such as a modification to its design, intended use, or manufacturing process, you must update your registration.

Summary of Steps for Class III MDACS Registration in Hong Kong:

1. Preparation:

   • Confirm device classification and appoint an authorized representative (if applicable).

   • Ensure ISO 13485 certification and prepare clinical data, risk management files, and other technical documents.

2. Application Submission:

   • Register online and complete the MDACS application form.

   • Submit all required technical documentation through the MDACS portal.

3. Review Process:

   • The DoH reviews the application, evaluates safety and efficacy data, and requests additional information if needed.

4. Approval:

   • If approved, the DoH issues a registration certificate valid for up to 5 years.

5. Post-Approval Compliance:

   • Maintain post-market surveillance, report adverse events, and submit any required updates or renewals.

6. Periodic Updates and Renewals:

   • Renew registration after 5 years and update technical documentation for any significant changes.

By following this process, you can successfully register your Class III medical device under MDACS and ensure that it complies with Hong Kong’s regulatory requirements.

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