The NMPA (National Medical Products Administration) certification process in China involves several specific regulations and requirements for application documents. Here are the key documents typically required:

1. Application Form: A completed application form provided by the NMPA, detailing basic information about the medical device and the applicant.

2. Device Description: Detailed description of the medical device, including its specifications, intended use, and technical parameters.

3. Quality Management System (QMS) Documentation: Evidence of compliance with relevant quality management standards (e.g., ISO 13485).

4. Clinical Evaluation Report: For certain classes of devices, a clinical evaluation report demonstrating safety and performance based on clinical data.

5. Risk Analysis Report: Identification and evaluation of potential risks associated with the device and measures to mitigate these risks.

6. Testing Reports: Test reports demonstrating compliance with applicable standards (e.g., GB or IEC standards) for safety, performance, and electromagnetic compatibility (EMC).

7. Labeling and Instructions for Use (IFU): Copies of labeling and IFU documents in Chinese, complying with local requirements.

8. Technical Documentation: Comprehensive technical documentation including design drawings, manufacturing processes, and materials used.

9. Authorization Documents: If applicable, documents demonstrating authorization from the original manufacturer to the applicant for distribution and sale in China.

10. Power of Attorney: A notarized power of attorney allowing a local representative in China to handle the application process.

11. Manufacturing License: For Class II and Class III devices, evidence of a valid manufacturing license issued by the relevant authorities in China.

12. Clinical Trial Data: If clinical trials were conducted in China, documentation related to the trials and their results.

These documents need to be carefully prepared and submitted according to the specific requirements outlined by the NMPA. It's advisable to work closely with a local consultant or legal representative familiar with Chinese regulatory requirements to ensure completeness and accuracy of the application.

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