The application procedure for Class III medical device MDACS registration in Hong Kong involves several key steps to ensure compliance with the Medical Device Administrative Control System (MDACS), which is managed by the Department of Health (DoH). Below is a detailed guide on the procedures involved:

1. Determine the Device Classification

First, verify that your medical device qualifies as a Class III medical device under Hong Kong regulations. Class III devices are considered high-risk and require extensive regulatory oversight.

• Class III devices typically include those that support or sustain human life, are implanted, or are used in situations where malfunction could result in significant harm.

Ensure that your device fits the Class III category by reviewing the relevant guidelines or consulting a regulatory expert.

2. Appoint an Authorized Representative (If Applicable)

If your company is located outside of Hong Kong, you must appoint an authorized representative in Hong Kong to act on your behalf. This representative will handle the registration process, submission of documents, and communication with the Department of Health (DoH).

The authorized representative must be a Hong Kong-based company or individual with a legal obligation to act as the liaison between the DoH and the manufacturer.

3. Prepare the Required Documentation

The following documents are essential to submit with your application for Class III medical device registration:

Required Documents for Class III MDACS Registration:

1. MDACS Application Form: A completed form with details about the manufacturer, device, and intended use.

2. ISO 13485 Certificate: Proof that the manufacturer complies with the ISO 13485 standard for medical devices and has a certified quality management system (QMS).

3. Clinical Evaluation Report: Documentation demonstrating the safety, effectiveness, and clinical performance of the device, including clinical trial data where applicable.

4. Device Description: Detailed information about the device's design, function, intended use, and risk classification.

5. Risk Management File: A file outlining the device's risk management process in accordance with ISO 14971 (Risk management for medical devices).

6. Manufacturing Information: Details about the manufacturing process, facilities, and quality control measures.

7. Labeling Information: Labels and Instructions for Use (IFU) that comply with Hong Kong's medical device labeling regulations.

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

4. Submit the Application

Once all documentation is prepared, submit the application via the MDACS online portal.

• Create an Account: If you do not already have one, create an account on the MDACS portal to start the submission process.

• Submit the Application Form and Documents: Complete the online application form with accurate and detailed information, and upload the required documents.

• Payment of Fees: Pay any applicable registration fees as outlined by the Department of Health. The fee is generally based on the device class and other factors.

5. Review Process by the Department of Health (DoH)

The Department of Health will review the submitted application, which typically involves the following steps:

• Initial Review: The DoH will first check the application for completeness, ensuring that all necessary documents have been submitted. Any missing or incomplete documentation will delay the process.

• Evaluation of Clinical and Technical Data: The DoH will evaluate the clinical evidence, technical documentation, and compliance with relevant safety and efficacy standards.

• Request for Clarification (if applicable): If the DoH requires additional information or clarification, they will reach out to you or your authorized representative. This may include further documentation or modifications to the submitted materials.

6. Decision

Once the DoH has reviewed the application and is satisfied with the information provided, they will make a decision:

• Approval: If the DoH is satisfied with the application, they will issue a registration certificate for the device. The registration certificate is typically valid for 5 years.

• Rejection: If the application does not meet the required standards, the DoH may reject the application, in which case you would need to revise the submission and address any issues raised by the DoH.

7. Post-Approval Compliance

Once the Class III medical device is approved and registered in Hong Kong, there are ongoing regulatory requirements that must be followed:

• Post-Market Surveillance: You must monitor the device’s performance and safety after it is placed on the market. This includes tracking adverse events and reporting them to the DoH if necessary.

• Annual Reports: Submit any required reports, such as annual updates on the device's performance or adverse events.

• Changes to the Device: If there are any significant changes to the device, its labeling, or manufacturing process, you must inform the DoH and seek approval for those changes.

8. Renew Registration

Class III medical device registration in Hong Kong is typically valid for 5 years. Before the expiration date, you must submit a renewal application with updated documentation and any new information regarding the device's safety, performance, or clinical data.

Key Considerations for the Application Process:

• Timeliness: Ensure that all required documentation is complete and submitted within the required timelines to avoid delays in the registration process.

• Accuracy: Provide accurate and detailed information to prevent the need for resubmissions or requests for additional documentation.

• Authorized Representative: Make sure your authorized representative in Hong Kong is well-versed in the MDACS registration process and can effectively communicate with the Department of Health.

• Monitoring Changes: Be aware of any changes to the MDACS regulations and ensure that your device remains compliant throughout its lifecycle.

By following these steps, you can navigate the MDACS registration process for Class III medical devices in Hong Kong successfully.

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