Applying for Class II Medical Device NMPA registration in China involves several key steps. Here’s a general outline of the process:

1. Preparation and Documentation:

   • Ensure your device meets the classification criteria and technical requirements for Class II devices in China.
   • Prepare essential documentation including technical files, clinical evaluation reports, risk assessment, labeling information, and manufacturing information.

2. Local Agent Appointment:

   • As a foreign manufacturer, appoint a qualified local agent in China who will represent you throughout the registration process.

3. Testing and Certification:

   • Conduct necessary testing according to Chinese standards or equivalent international standards recognized by NMPA.
   • Obtain certifications or test reports from accredited laboratories.

4. Application Submission:

   • Submit the application through the NMPA's online registration platform. Prepare to provide detailed information about the device, manufacturing process, and clinical data if applicable.

5. Review and Evaluation:

   • NMPA will review your application, technical documents, and test reports. This process may involve several rounds of feedback and clarification.

6. Onsite Inspection (if required):

   • Depending on the risk classification and type of device, an onsite inspection of your manufacturing facilities may be required by NMPA inspectors or designated third-party organizations.

7. Approval and Certification:

   • Upon successful review and inspection (if applicable), NMPA will issue a registration certificate for your Class II medical device.

8. Post-Market Surveillance:

   • Comply with post-market surveillance requirements, including adverse event reporting, quality management system maintenance, and periodic reporting to NMPA.

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