To apply for Class I medical device registration with China's National Medical Products Administration (NMPA), certain conditions must be met to ensure compliance with Chinese regulatory requirements. Here are the key conditions that typically apply:

1. Device Classification:

   • Your device must meet the criteria for Class I classification under Chinese regulations. Class I devices are generally low-risk and non-invasive in nature.

2. Quality Management System (QMS):

   • Implement and maintain a quality management system (QMS) that meets the requirements of ISO 13485 or an equivalent standard. This ensures that your device is manufactured under controlled processes that adhere to quality and safety standards.

3. Technical Documentation:

   • Prepare comprehensive technical documentation that includes:
     • Device description: Detailed information about the device’s design, intended use, and specifications.
     • Manufacturing details: Description of the manufacturing process, materials used, and quality control measures.
     • Risk assessment: Evaluation of potential risks associated with the device and mitigation measures implemented.
     • Testing reports: Documentation demonstrating compliance with applicable standards and regulations, including biocompatibility, electrical safety, and performance testing.
     • Instructions for Use (IFU): Clear and comprehensive instructions for users on how to correctly use the device.

4. Clinical Evaluation (if required):

   • Determine if a clinical evaluation is necessary for your device based on its classification and intended use. Class I devices typically do not require clinical trials unless specific circumstances warrant it.

5. Local Agent Appointment:

   • If you are a foreign manufacturer, appoint a qualified local agent in China. The local agent will act as your representative for regulatory affairs and communication with the NMPA.

6. Compliance with Chinese Regulations:

   • Ensure that your device complies with all relevant Chinese regulations, standards, and directives applicable to Class I medical devices.

7. Translation Requirements:

   • All documentation submitted to the NMPA must be translated into Chinese. This includes technical documents, instructions for use, and any other relevant materials.

8. Submission Process:

   • Submit your application through the NMPA’s designated platform or system, following their specific guidelines and requirements for document formatting, submission protocols, and electronic formats.

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