To apply for Class I medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you need to prepare specific materials and documents. Below is a comprehensive list of required materials and guidance on how to prepare them for your application.

Required Materials for Class I Medical Device MDACS Registration

1. Device Description

   • Detailed Description of the Device:

     • Name, model, and version (if applicable).

     • Intended use, indications, and target population.

     • Device design and components.

   • Device Specifications:

     • Physical and technical characteristics of the device (e.g., size, materials used, working principles).

2. Conformity to Safety and Performance Standards

   • Declaration of Conformity:

     • This document confirms that the device meets relevant safety and performance standards, typically including:

       • ISO 13485 (Quality Management Systems).

       • ISO 14971 (Risk Management).

       • IEC 60601 (Electrical Safety and Performance) for electrical medical devices.

     • Alternatively, you can submit proof of approval from other regulatory authorities (e.g., CE mark, FDA clearance), provided the device complies with those standards.

3. Labeling Information

   • Product Labeling: Provide details of all labeling on the device packaging, which should include:

     • The manufacturer's or distributor's name and address.

     • Instructions for use, precautions, warnings, and contraindications.

     • Any symbols or regulatory marks (e.g., CE mark, FDA registration number, etc.).

     • Unique Device Identifier (UDI) if applicable.

4. Risk Assessment

   • While Class I devices are generally considered low-risk, you must provide a basic risk assessment to demonstrate compliance with ISO 14971 (Risk Management). This could include:

     • Identification of potential hazards associated with the device.

     • Measures to mitigate risks, if applicable.

     • Consideration of intended use and user population.

5. Manufacturing Information

   • Manufacturer's Details: Include the name, address, and contact information of the manufacturer (and LRP if applicable).

   • Manufacturing Process: A brief outline of the manufacturing process, quality control measures, and any third-party testing or certification.

   • Device’s Quality Assurance Procedures: This may include details on compliance with Good Manufacturing Practices (GMP) or ISO 13485.

6. Local Responsible Person (LRP) Information (for overseas manufacturers)

   • If you are an overseas manufacturer, you are required to appoint a Local Responsible Person (LRP) in Hong Kong. The LRP will:

     • Act as your representative for regulatory matters.

     • Be responsible for submitting the registration application.

     • Handle post-market surveillance (e.g., reporting adverse events).

   You must submit the LRP’s contact details and proof of their registration in MDACS.

How to Prepare Application Documents

1. Prepare Device Descriptions and Specifications

• Provide a clear and detailed description of the device. Ensure it includes the intended use, key features, and any technical specifications that describe the device's functioning and its intended medical purpose.

2. Gather Conformity Documents

• Ensure that you have up-to-date certificates such as:

  • CE mark certificates (if applicable).

  • FDA 510(k) clearance (if applicable).

  • ISO 13485 certificate.

  • Any risk management documentation (e.g., risk analysis based on ISO 14971).

• If you do not have certificates from another regulatory authority, prepare a Declaration of Conformity confirming that your device complies with relevant safety and performance standards.

3. Compile Labeling Information

• Ensure the labeling is complete with:

  • Manufacturer’s name, device name, and intended use.

  • Instructions for safe use, warnings, and any necessary symbols.

  • UDI or device identification number, if required by local regulations.

• If your device is distributed globally, verify that the labeling complies with international standards for medical devices (e.g., CE or FDA requirements).

4. Conduct a Risk Assessment

• Even for low-risk Class I devices, you should perform a basic risk analysis to demonstrate that you have assessed potential hazards. The assessment should cover:

  • Use-related risks.

  • Environmental factors affecting device safety.

  • How risks are mitigated (e.g., material selection, design choices).

• ISO 14971 is the international standard for risk management, and a risk report based on this document will strengthen your application.

5. Confirm Manufacturing and Quality Information

• Ensure you have detailed information about your manufacturing processes, quality assurance practices, and compliance with industry standards such as ISO 13485 (Quality Management Systems).

• Include any relevant quality control documentation showing that the device is manufactured under controlled conditions.

6. Submit Local Responsible Person (LRP) Details

• If you're an overseas manufacturer, ensure that you have appointed an LRP based in Hong Kong.

• Submit proof of the LRP's registration with the Hong Kong Department of Health and their contact details. The LRP will manage the registration process and act as your point of contact for any regulatory matters in Hong Kong.

Precautions During the Application Process

1. Accuracy of Documentation

   • Ensure that all documents are accurate and up-to-date. Any discrepancies in labeling or non-compliance with international standards can delay or prevent approval.

2. Language Requirements

   • Ensure all documents are written in English or Chinese. You may need to provide translations for some documents if they are not already in one of these languages.

3. Device Classification

   • Double-check that your device qualifies as Class I. If there’s any uncertainty, refer to the Medical Device Classification Guidelines or consult with an expert.

4. Timely Submission

   • Be aware of processing timelines. The review process typically takes up to 12 weeks for Class I devices, so submit the application well ahead of your intended market launch.

5. Post-Market Surveillance

   • After registration, you must comply with post-market surveillance requirements, including:

     • Reporting adverse events or incidents.

     • Conducting recalls or corrective actions when necessary.

Conclusion

The process for Class I medical device MDACS registration in Hong Kong is relatively straightforward, but preparing the necessary documents accurately and ensuring compliance with all regulatory requirements is critical for a successful application. Following the steps outlined above will help you prepare the necessary materials and submit a complete and compliant application.

For detailed guidance on document preparation and to start your application, visit the official MDACS page: MDACS Registration Information.

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