Applying for NMPA (National Medical Products Administration) registration for Class III medical devices in China involves several steps. Here's a general overview of the process:

1. Preparation and Submission of Documents: Prepare all required documents, including technical documentation, clinical trial data (if applicable), manufacturing information, and quality management system certification (e.g., ISO 13485). These documents need to be submitted to the NMPA.

2. Local Testing: In some cases, local testing in China may be required for your medical device to comply with Chinese standards and regulations. Ensure your device meets all applicable standards.

3. Clinical Trials (if applicable): For Class III devices, clinical trial data may be required to demonstrate safety and efficacy. Ensure the trials are conducted according to Chinese regulations and standards.

4. Appointment of a Local Agent: You need to appoint a local agent or representative in China who will handle communication with the NMPA on your behalf. This agent should be registered with the NMPA.

5. Submission to NMPA: Submit your application and all supporting documents to the NMPA through the designated online platform or in person at the NMPA office. Ensure all documents are properly translated into Chinese.

6. Review and Evaluation: The NMPA will review your application and documents to ensure compliance with Chinese regulations. This process may involve several rounds of review and feedback.

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

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

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn