Yes, the application for NMPA (National Medical Products Administration) certification in China typically requires supporting import documents, especially for foreign manufacturers looking to get their medical devices approved for the Chinese market. Here are the key import document supports that are generally required during the NMPA certification application process:

Key Import Document Supports for NMPA Certification

1. Business License of the Local Agent:

   • If the manufacturer is foreign, a copy of the local agent's business license in China is needed. This serves as evidence that the agent is authorized to conduct business and represent the manufacturer in China.

2. Power of Attorney:

   • A formal power of attorney document must be issued by the foreign manufacturer to the local agent, granting them the authority to act on behalf of the manufacturer throughout the registration and import processes.

3. 
   

4. 
   

5. Quality Management System Certificates:

   • Evidence of quality management system certification, like ISO 13485, is often required to demonstrate compliance with international standards for medical device manufacturing.

6. Product Registration Certificate (if applicable):

   • For devices that may have previously been registered in other countries, copies of existing registration certificates from regulatory authorities (such as FDA, CE mark, etc.) may be required. This can help to streamline the approval process.

7. Technical Dossier:

   • The application must include a technical dossier containing comprehensive information about the device's design, manufacturing processes, labeling, and safety and efficacy data.

8. Testing Reports:

   • Reports from recognized laboratories demonstrating that the medical device meets the relevant Chinese national standards (GB standards) or equivalent international standards.

9. Clinical Evaluation Report:

   • If the device is classified as Class II or III, a clinical evaluation report based on clinical data must be included, which may require local clinical trial data in some instances.

10. Sample of Device Labeling:

    • Samples of the labeling and instructions for use, translated into Chinese, must accompany the application to ensure compliance with local regulations.

11. Customs Documentation:

    • If applicable, any customs-related documentation must be prepared ahead of the importation process, informing authorities of the nature of the goods being imported.

Conclusion

In summary, supporting import documents are indeed an essential part of the application process for NMPA certification, particularly for foreign manufacturers. It’s crucial to compile all necessary documents accurately to facilitate the registration process and ensure compliance with Chinese regulations. If you have any specific questions or need clarification on certain requirements, feel free to ask!

Contact Us：

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