Before applying for Class III medical device MDACS registration in Hong Kong, proper preparation is key to ensuring that your application meets all the regulatory requirements and facilitates a smooth registration process. Below are the essential steps and considerations for preparing for the application:

1. Understand the MDACS Regulations

• Familiarize Yourself with MDACS: Ensure that you understand the requirements under the Medical Device Administrative Control System (MDACS), specifically for Class III medical devices. This includes the technical documentation, safety, performance requirements, and applicable standards.

• Device Classification: Confirm that your device falls under Class III by reviewing the medical device classification rules in Hong Kong. Class III devices are generally high-risk devices that require more stringent regulation.

2. Appoint a Local Authorized Representative

• Non-Hong Kong Manufacturers: If your company is located outside of Hong Kong, you will need to appoint a local authorized representative (AR) in Hong Kong. The AR acts as a liaison with the Hong Kong Department of Health (DoH) and ensures compliance with local regulations.

• AR Responsibilities: The AR is responsible for submitting registration applications, maintaining regulatory compliance, and handling communications from DoH.

3. Prepare Required Documentation

Ensure that all the necessary technical and regulatory documents are ready for submission. These documents must demonstrate that your device meets safety, efficacy, and quality standards. Typical documents required for Class III MDACS registration include:

• Manufacturer Information: Company name, address, and contact details.

• Device Description: Detailed description of the medical device, including its intended use, operating principles, and classification rationale.

• Risk Management File: A risk analysis document, usually in accordance with ISO 14971, showing how risks associated with the device are identified, evaluated, and mitigated.

• Clinical Evaluation Report (CER): Clinical data to support the safety and performance claims of the device, often required for Class III devices.

• Device Labeling: Labels, instructions for use (IFU), and packaging information in compliance with Hong Kong’s requirements (e.g., bilingual labeling).

• Quality Management System (QMS) Certificate: Evidence of compliance with ISO 13485 or other applicable quality standards.

• CE Mark or Other Regulatory Approvals: If your device is already approved in other markets (e.g., CE, FDA), you can submit these approvals as supporting documentation.

4. Ensure Compliance with International Standards

• ISO Standards: Your device should meet the requirements of ISO standards, such as ISO 13485 (Quality Management Systems for Medical Devices), ISO 14971 (Risk Management), and ISO 10993 (Biocompatibility).

• Compliance with Other Jurisdictions: If the device has been approved in other markets (e.g., EU, US), ensure that the documents from these regions are in line with Hong Kong requirements. This can help streamline the registration process.

• Electromagnetic Compatibility (EMC) and Safety Testing: Ensure that the device has undergone testing for electromagnetic compatibility (EMC) and electrical safety, if applicable.

5. Prepare for Local Testing and Evaluation

• Depending on the nature of the device, some local testing may be required to demonstrate compliance with Hong Kong’s medical device safety and performance standards.

• Third-Party Testing Labs: If necessary, engage third-party testing laboratories that are recognized by the Hong Kong authorities to conduct the required tests.

6. Prepare for the Regulatory Fee Payment

• The MDACS registration fee is applicable and must be paid during the application submission. Ensure that the required fee is prepared in advance to avoid delays in the registration process.

7. Ensure Proper Labeling and Language Compliance

• Bilingual Labeling: Ensure that the device's labeling, including instructions for use (IFU) and packaging, complies with the bilingual requirement in Hong Kong (Chinese and English).

• Labeling Compliance: Verify that the labels include the Hong Kong registration number and relevant safety and regulatory information.

• Instructions for Use (IFU): Ensure that the IFU complies with Hong Kong’s requirements and includes adequate information for safe and effective use.

8. Plan for Post-Market Surveillance (PMS)

• PMS System: Develop a post-market surveillance system to track the safety and performance of the device once it is on the market.

• Adverse Event Reporting: Have a system in place to report any adverse events or safety issues with the device to the Hong Kong Department of Health in a timely manner.

9. Review and Verify the Application Package

• Complete Documentation: Double-check that all required documents are included and complete. Missing or incomplete documentation can result in delays or rejections.

• Accuracy and Consistency: Ensure that all details in the documents (e.g., device description, risk management plan, clinical data) are consistent with the information in the device's technical file.

• Quality of Submission: Prepare the documents in a clear, professional format. Use official templates or formats provided by the Hong Kong Department of Health, if available.

10. Submit the Application to MDACS

• Submission: Submit your completed application, along with the required documents and the appropriate fee, to the Medical Device Control Office (MDCO) under the Hong Kong Department of Health (DoH).

• Application Tracking: Once submitted, track the application status and be ready to respond promptly to any requests for additional information or clarification from the Department of Health.

Summary of Preparations for Class III MDACS Registration in Hong Kong

1. Understand MDACS Regulations and confirm the device classification.

2. Appoint a Local Authorized Representative (if applicable).

3. Prepare Required Documentation: Ensure all documents (e.g., device description, clinical evaluation, risk management, QMS certificates) are ready.

4. Ensure Compliance with International Standards like ISO 13485, ISO 14971, and others.

5. Prepare for Local Testing: Verify testing requirements and engage accredited labs if needed.

6. Prepare for Regulatory Fee Payment.

7. Ensure Labeling Compliance with bilingual and other regulatory requirements.

8. Plan for Post-Market Surveillance.

9. Review and Verify that the application package is complete and accurate.

10. Submit the Application to the MDCO, Department of Health.

By thoroughly preparing these steps, you’ll be better equipped to submit a successful Class III medical device MDACS registration application in Hong Kong. Let me know if you need further guidance on any specific part of the process!

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