Applying for NMPA (National Medical Products Administration) registration for medical devices in China involves several key steps and requirements. Here’s a general overview of the process:

1. Classification of Your Device: Determine the classification of your medical device according to China's classification rules (Class I, II, or III). This classification will determine the applicable regulatory requirements.

2. Local Representative: If you are a foreign manufacturer, appoint a local representative or agent in China. This representative will liaise with the NMPA on your behalf.

3. Technical Documentation Preparation: Prepare technical documentation, including:

   • Device description and specifications
   • Design and manufacturing information
   • Risk analysis and mitigation measures
   • Testing and validation data
   • Clinical evaluation data (if required)
   • Labeling and Instructions for Use (IFU)

4. Quality Management System: Implement a Quality Management System (QMS) compliant with NMPA requirements. This may involve obtaining ISO 13485 certification.

5. Clinical Evaluation (if required): For higher-risk devices, clinical evaluation data may be required to demonstrate safety and efficacy.

6. Application Submission: Submit your application through the NMPA's online platform or through your local representative. Include all required documentation and pay the application fees.

7. Review and Approval: The NMPA will review your application and technical documentation. They may conduct inspections or request additional information during the review process.

8. Post-Market Surveillance: After obtaining registration, comply with post-market surveillance requirements, including reporting adverse events and maintaining regulatory compliance.

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