The process for NMPA (National Medical Products Administration) registration of medical devices in China generally involves several key steps and processes:

1. Device Classification: Determine the classification of your medical device according to China's classification rules (Class I, II, or III). This classification will dictate the regulatory requirements and the specific registration pathway.

2. Local Representative: If you are a foreign manufacturer, appoint a local representative or agent in China. This representative will act as your liaison with the NMPA and facilitate communications.

3. Quality Management System (QMS): Establish and maintain a Quality Management System (QMS) that complies with NMPA requirements. This often includes obtaining ISO 13485 certification, which is preferred by the NMPA.

4. Technical Documentation Preparation: Prepare comprehensive technical documentation, including:

   • Device description, specifications, and intended use
   • Design and manufacturing information
   • Risk assessment and mitigation measures
   • Testing and validation data (e.g., performance testing, biocompatibility testing)
   • Clinical evaluation data (if required for higher-risk devices)
   • Labeling and Instructions for Use (IFU) in Chinese

5. Clinical Evaluation (if required): For higher-risk devices, clinical evaluation data may be necessary to demonstrate safety and efficacy. This involves conducting clinical trials or providing literature-based evidence.

6. Application Submission: Compile all required documentation and submit your application through the NMPA's online registration platform or via your local representative. Ensure that all forms are completed accurately and include payment of applicable fees.

7. Technical Review: The NMPA will conduct a technical review of your submission, which may include evaluating the technical documentation, QMS compliance, and clinical data (if applicable). They may request additional information or clarifications during this stage.

8. On-Site Inspection (if required): Depending on the device classification and risk level, the NMPA may conduct an on-site inspection of your manufacturing facilities to verify compliance with regulatory standards.

9. Approval and Registration: Upon successful completion of the review process and any necessary inspections, the NMPA will issue a registration certificate for your medical device. This certificate allows you to legally market and distribute your device in China.

10. Post-Market Surveillance: After obtaining registration, comply with post-market surveillance requirements, including monitoring adverse events, maintaining regulatory updates, and reporting any changes or modifications to the device.

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