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

1. Classification of Device: Determine the classification of your medical device according to the NMPA regulations. This classification will dictate the requirements and pathway for registration.

2. Local Representative: For foreign manufacturers, appoint a local representative or an authorized agent in China who can communicate with the NMPA on your behalf.

3. Documentation Preparation: Prepare all necessary documents, including:

   • Device testing reports (e.g., clinical evaluation, performance testing).
   • Quality management system (QMS) documentation (e.g., ISO 13485 certification).
   • Manufacturing process information.
   • Product labeling and instructions for use (IFU) in Chinese.
   • Risk assessment report.
   • Summary of product technical requirements.

4. Clinical Trial Data (if applicable): If clinical trials are required for your device category, ensure you have conducted and documented these trials according to NMPA regulations.

5. Application Submission: Submit your application to the NMPA. The application should include all required documentation, typically in both Chinese and English.

6. Review and Evaluation: The NMPA will review your application and documentation. This process includes technical review, clinical evaluation (if applicable), and inspection of manufacturing facilities.

7. Registration Certificate Issuance: If your application is successful, the NMPA will issue a registration certificate allowing you to market and sell your medical device in China.

8. Post-Market Surveillance: After obtaining registration, comply with post-market surveillance requirements, including adverse event reporting and device monitoring.

Contact Us：

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