To apply for NMPA (National Medical Products Administration) registration of medical devices in China, certain conditions must be met to ensure compliance with regulatory requirements. Here are the key conditions:

1. Device Classification: Determine the correct classification of your medical device according to NMPA regulations. Devices are categorized into Classes I, II, or III based on their potential risks and intended use. Each class has specific regulatory requirements for registration.

2. Quality Management System (QMS):

   • Implement and maintain a Quality Management System (QMS) that meets international standards, such as ISO 13485 or an equivalent standard recognized by the NMPA.
   • Ensure that your QMS covers all aspects of device design, manufacturing, testing, and post-market surveillance.

3. Technical Documentation:

   • Prepare comprehensive technical documentation that includes:
     • Device description and specifications.
     • Design rationale and engineering drawings.
     • Testing reports (e.g., performance testing, biocompatibility testing, electrical safety testing).
     • Risk management documentation, including hazard analysis and mitigation measures.
     • Clinical data and evaluations, especially for Class II and III devices. This may include clinical trial reports conducted in accordance with NMPA requirements.

4. Labeling and Instructions for Use (IFU):

   • Ensure that labeling and IFU are in compliance with NMPA requirements.
   • Labels must include device identification, usage instructions, warnings, precautions, and other required information in Chinese.

5. Manufacturing Compliance:

   • Demonstrate compliance with Good Manufacturing Practice (GMP) regulations or an equivalent quality standard. Provide details about manufacturing facilities, processes, and controls.

6. Clinical Data (if applicable):

   • For Class II and III devices, provide clinical evaluation data that demonstrates the safety and efficacy of the device.
   • Clinical trials may be required as part of the submission, conducted in accordance with NMPA guidelines and ethical standards.

7. Authorized Agent or Representative:

   • Foreign manufacturers must appoint a local agent or authorized representative in China. This representative acts on behalf of the manufacturer for communication with the NMPA and other regulatory matters.

8. Application Submission:

   • Submit the application and all required documentation through the NMPA’s designated online platform or through authorized third-party service providers.

9. Post-Market Surveillance Plan:

   • Develop and implement a post-market surveillance plan to monitor the device’s performance and safety after it enters the market. This includes reporting adverse events and complying with periodic reporting requirements to the NMPA.

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