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

1. Classification Verification: Ensure your medical device is classified correctly under China's regulatory framework. Class III devices typically include high-risk products such as implantable devices and life-supporting devices.

2. Technical Documentation Preparation: Compile all necessary technical documentation, including device descriptions, design specifications, manufacturing processes, and labeling information. This documentation should demonstrate compliance with Chinese standards and regulations.

3. Quality Management System Certification: Obtain ISO 13485 certification or an equivalent quality management system certification recognized by the NMPA.

4. Clinical Evaluation (if applicable): For Class III devices, clinical evaluation data may be required to demonstrate safety and efficacy. Conduct clinical trials in China or provide clinical data that meets Chinese regulatory requirements.

5. Local Testing (if required): Some devices may require testing in China to ensure compliance with Chinese standards and regulations. Arrange for testing at accredited Chinese laboratories if necessary.

6. Appointment of a Local Agent: Designate a local agent or representative in China who is registered with the NMPA. This agent will act on your behalf for communication and regulatory affairs.

7. Application Submission: Prepare and submit your application and all supporting documents through the NMPA's online portal or by physical submission at the NMPA office. Ensure all documents are translated into Chinese.

8. Review and Evaluation: The NMPA will review your application, technical documentation, and any clinical data provided. This process may involve several rounds of review and may require additional information or clarification.

9. On-site Inspection (if applicable): Depending on the device type and application, the NMPA may conduct an on-site inspection of your manufacturing facilities to verify compliance with regulations.

10. Approval and Registration: If your application meets all requirements and passes review, the NMPA will issue a registration certificate. This certificate allows you to legally market and sell your Class III medical device in China.

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

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