To register and apply for Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), you need to follow a detailed process that involves preparing comprehensive documentation, submitting an application, and undergoing a review process. Below are the steps to follow for the registration and application of Class IV medical devices under MDACS:

Step-by-Step Process for Class IV Medical Device Registration under MDACS:

1. Verify Device Classification

Before starting the registration process, verify that your device is indeed classified as Class IV under the MDACS system. Class IV devices are considered high-risk and include those that are implantable, life-supporting, or pose significant risk to health. These devices require the most extensive regulatory scrutiny.

2. Prepare the Required Documentation

You need to provide a comprehensive set of documentation to support your application. This documentation ensures that the device meets all safety, efficacy, and regulatory requirements. Required materials include:

A. Technical Documentation:

• Device Description: A detailed description of the device, its intended use, and its design.

• Risk Management: A risk management file based on ISO 14971 (Risk Management for Medical Devices), including risk analysis, mitigation measures, and ongoing monitoring procedures.

• Clinical Data: Clinical evaluation reports, including results from clinical trials, post-market data, or scientific literature demonstrating the device’s safety and efficacy.

• Performance and Safety Testing: Evidence of testing compliance with standards (e.g., IEC 60601 for electrical safety, ISO 10993 for biocompatibility, etc.).

• Manufacturing Information: Details of the manufacturing process and proof of compliance with Good Manufacturing Practice (GMP).

• Labeling and Instructions for Use (IFU): A copy of the device labeling and IFU, including any necessary warnings and precautions as required by MDACS.

B. Quality Management System (QMS):

• ISO 13485 Certification: Proof that the manufacturer operates under a Quality Management System that complies with ISO 13485 (Medical Devices—Quality Management Systems).

C. Certification and Approvals:

• Free Sale Certificate: Evidence that the device is marketed and available for sale in another region or country (e.g., CE mark, FDA approval).

• Declaration of Conformity: A statement from the manufacturer confirming that the device complies with the relevant regulatory requirements.

3. Appoint an Authorized Representative (if applicable)

If your company is based outside Hong Kong, you will need to appoint an authorized representative in Hong Kong. This representative will handle the registration process and act as a liaison between the manufacturer and the Hong Kong Department of Health (DH).

4. Submit the Application

Once all documentation is prepared, the application must be submitted to the Hong Kong Department of Health via the MDACS system. This can be done through the MDACS online portal or directly through the Department of Health. Here's how to proceed:

A. Application Form:

• Complete the MDACS application form, which includes:

  • Device information (name, type, classification)

  • Manufacturer and authorized representative details

  • Intended use and indications

  • Device risk class and evidence for classification as a Class IV device.

B. Required Documents:

• Submit the necessary technical documents, including the risk management report, clinical data, test results, and quality system certifications.

• Submit a copy of the labeling and instructions for use (IFU).

• Attach the Free Sale Certificate or Declaration of Conformity (if applicable).

C. Fees:

• Payment of Application Fees: Pay the appropriate registration fees as required by the Department of Health. For Class IV devices, fees tend to be higher due to the complexity and level of scrutiny involved in the evaluation.

5. Evaluation and Review

Once the application is submitted, the Hong Kong Department of Health will conduct a detailed evaluation. This includes:

• Documentary Review: The Department will assess all submitted documentation for completeness and compliance with relevant standards.

• Technical Evaluation: This involves evaluating the clinical data, risk management reports, and performance test results to ensure the device meets safety and effectiveness standards.

• Inspection (if applicable): In some cases, the Department may conduct an inspection of the manufacturing facilities to verify compliance with Good Manufacturing Practices (GMP).

• Request for Additional Information: The Department may request additional documentation or clarification if necessary.

6. Approval and Registration

After the review, if the device is deemed compliant, the Hong Kong Department of Health will grant the Class IV medical device registration and issue a registration certificate. This certificate allows you to market the device in Hong Kong.

7. Post-Approval Requirements

After obtaining the registration, you must comply with ongoing post-market surveillance requirements:

• Post-Market Surveillance: Monitor the device’s safety and performance on the market. Report any adverse events, product defects, or recalls to the Department of Health.

• Annual Reporting: You may be required to submit periodic updates regarding the device’s performance.

• Renewal: The registration is valid for 5 years, and you must apply for renewal before the registration expires.

Summary of Steps for Class IV Medical Device Registration under MDACS:

1. Verify Device Classification: Ensure the device is classified as Class IV.

2. Prepare Documentation: Gather all required technical, clinical, and regulatory documentation.

3. Appoint an Authorized Representative (if applicable): If based outside Hong Kong, appoint a local representative.

4. Submit Application: Complete the application form and submit it to the Hong Kong Department of Health along with the necessary documentation and fees.

5. Evaluation and Review: The Department of Health will review the application, assess compliance, and potentially inspect the manufacturing site.

6. Approval and Registration: Upon successful evaluation, the device will be registered, and you will receive a registration certificate.

7. Post-Approval Compliance: Maintain post-market surveillance and apply for renewal of registration every 5 years.

By following these steps, you can ensure that your Class IV medical device is correctly registered under Hong Kong's MDACS, allowing you to legally market and distribute the device in Hong Kong.

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