Obtaining NMPA (National Medical Products Administration) registration for medical devices in China involves meeting several key requirements. These requirements can vary depending on the classification of the medical device (Class I, II, or III) and its intended use. Here are the general requirements:

1. Classification and Risk Assessment: Determine the classification of your medical device according to China's classification rules. Classify the device based on its intended use, potential risks to patients, operators, and others, and the duration of contact with the human body.

2. Quality Management System (QMS): Implement a Quality Management System (QMS) that complies with relevant standards. The NMPA typically requires manufacturers to have ISO 13485 certification, which demonstrates compliance with international QMS standards specific to medical devices.

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

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

4. Clinical Evaluation (if applicable): For higher-risk devices, provide clinical evaluation data to demonstrate the safety and efficacy of the device. This may involve clinical trials or literature-based evidence depending on the device classification.

5. Local Agent or Representative: If you are a foreign manufacturer, appoint a local agent or representative in China. This representative acts as the point of contact with the NMPA and assists with regulatory submissions and communications.

6. Application Submission: Compile all required documentation and submit your registration application through the NMPA's online 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, assessing the technical documentation, QMS compliance, and any clinical data provided. They may request additional information or clarifications during the review process.

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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