Before applying for Class A medical device registration under Hong Kong MDACS (Medical Device Administrative Control System), there are several key preparatory steps you should take to ensure a smooth and successful application process. Here’s a comprehensive guide on what preparations to make:

1. Understand the Classification Criteria

• Confirm the Device Classification: Ensure your device qualifies as Class A under the MDACS classification system. Class A devices are generally non-invasive, non-sterile, and pose minimal risk to users. Review the MDACS classification guidelines (GN-01) to determine the exact classification of your device.

• If you're unsure about the classification, consult the Hong Kong Department of Health (DH) or consider seeking professional advice.

2. Prepare the Required Documentation

Ensure you have all the necessary documents to submit with your application. This includes:

• Device Information: Details about the medical device, including its intended use, design, functionality, and technical specifications.

• Labeling: The device's labels and instructions for use (IFU) must comply with Hong Kong requirements, including bilingual (English and Traditional Chinese) labeling.

• Manufacturer Information: Details about the device manufacturer, including the manufacturing address and any relevant certifications (e.g., ISO 13485 if applicable).

• Declaration of Conformity: A declaration of conformity indicating that the device meets the relevant safety and performance requirements.

• Risk Management Documentation: Although Class A devices are low-risk, some documentation around risk management may be required, especially if the device involves electrical components or other potential hazards.

• Quality Management System Documentation: While ISO 13485 is not mandatory for Class A devices, it’s still good practice to have a documented quality management system in place to ensure compliance with good manufacturing practices (GMP).

3. Appoint a Local Responsible Person (LRP)

• For Foreign Manufacturers: If you are a manufacturer based outside Hong Kong, you are required to appoint a Local Responsible Person (LRP) in Hong Kong. The LRP acts as the official representative for your device and is responsible for ensuring that the device complies with local regulations.

• Ensure that the LRP is registered with the Hong Kong Department of Health and has the necessary expertise to handle regulatory matters.

4. Review MDACS Guidelines (GN-01)

• Guideline GN-01 provides specific instructions on Class A device registration under MDACS. Review this guideline carefully to understand the full scope of requirements and ensure that your application meets the standards set by the Hong Kong Department of Health.

• Pay attention to details such as device classification criteria, labeling requirements, and documentation expectations.

5. Ensure Compliance with Local Standards

• While Class A devices are lower-risk, they must still comply with Hong Kong’s medical device regulations. Ensure your device aligns with relevant product safety standards, such as ISO 14971 (risk management), ISO 10993 (biological evaluation), and others depending on your device type.

• If your device has electrical components, it should also comply with IEC 60601-1 or similar standards for electrical safety.

6. Prepare for Post-Market Surveillance and Reporting

• Although Class A devices are low-risk, the Hong Kong Department of Health may still require periodic post-market surveillance. Prepare to implement systems for:

  • Monitoring the device’s performance after it’s on the market.

  • Adverse event reporting in the event of device malfunctions or risks to patient safety.

  • Device recalls if any safety issues arise post-market.

7. Ensure Accurate and Complete Labeling

• Labeling Requirements: Your device must meet Hong Kong’s labeling standards, which include:

  • Product name, model, and serial number.

  • Manufacturer’s name and contact information.

  • Bilingual labeling (English and Traditional Chinese).

  • Instructions for use (IFU) that describe the proper use of the device, safety instructions, and potential risks.

• Prepare the IFU and ensure it is clear, concise, and compliant with the regulatory guidelines.

8. Consult an Expert or Regulatory Affairs Consultant

• If you are unfamiliar with the Hong Kong MDACS registration process or if the device has more complex features, it can be beneficial to consult with a regulatory affairs consultant or legal expert who is experienced in medical device registration in Hong Kong. They can guide you through the process and ensure all requirements are met.

9. Ensure Quality Control and GMP Compliance

• While Class A devices are low-risk, ensuring good manufacturing practices (GMP) is crucial. If applicable, implement or maintain an ISO 13485-compliant quality management system to demonstrate the consistent quality of your device.

• Conduct regular internal audits and quality checks to ensure your device remains compliant with all regulations.

10. Prepare for the Application Submission

• Once all documentation is ready and you have appointed your Local Responsible Person (LRP), ensure that you understand the submission process and fees involved with the Hong Kong Department of Health.

• Familiarize yourself with the online submission platform (if applicable) or prepare the necessary paperwork to submit the application.

• Double-check all documents for completeness and accuracy to avoid delays or requests for additional information.

11. Plan for Timelines and Follow-Up

• Be aware of the typical processing times for Class A medical device registration. Although it is generally quicker than higher-class devices, ensure that you allocate enough time to account for any delays.

• Plan for follow-up actions, such as responding to queries from the Department of Health or addressing any additional requirements.

📑 Summary of Preparations:

1. Confirm Classification: Ensure your device is Class A under MDACS.

2. Gather Required Documents: Device info, labeling, instructions, risk management, and quality system documentation.

3. Appoint a Local Responsible Person (LRP) (if based outside Hong Kong).

4. Review MDACS Guidelines (GN-01) for device classification and requirements.

5. Ensure Compliance with Relevant Standards (e.g., ISO 13485, ISO 14971).

6. Prepare Post-Market Surveillance Systems for ongoing safety monitoring.

7. Ensure Proper Labeling in English and Traditional Chinese.

8. Consult Experts if needed for guidance on MDACS registration.

9. Prepare Quality Control Processes and GMP compliance.

10. Submit Application once all materials are complete and correct.

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