When applying for NMPA (National Medical Products Administration) certification in China for medical devices, several key documents must be submitted. Each of these documents has specific terms and conditions that applicants need to adhere to. Below is an overview of the typical requirements:

1. **Application Form**:

   - Complete the NMPA application forms, which include details about the manufacturer, the device, and the intended use.

   - Ensure accuracy and consistency of information across all documents.

2. **Product Technical Documentation**:

   - Includes design, manufacturing process, and quality control procedures. 

   - Documentation must align with applicable Chinese standards (GB standards) and demonstrate product safety and efficacy.

3. **Quality Management System (QMS) Documents**:

   - Evidence of compliance with ISO 13485 or relevant QMS certification.

   - Maintenance of documentation is essential; it must be up-to-date and reflect actual practices.

4. **Clinical Evaluation Report**:

   - A thorough assessment of clinical data supporting the safety and performance of the device.

   - Must comply with NMPA guidelines on clinical evaluation and may require local clinical trial data in some cases.

5. **Product Testing Reports**:

   - Reports from recognized laboratories demonstrating compliance with safety and performance standards.

   - Testing must be conducted according to Chinese standards or equivalent international standards recognized by the NMPA.

6. **Labels and Instructions for Use**:

   - Must be in Chinese and include all necessary information, including usage instructions, contraindications, and safety warnings.

   - Ensure that labeling complies with NMPA requirements.

7. **Declaration of Conformity**:

   - A document affirming that the product complies with relevant regulations and standards.

   - This may need to be signed by a responsible person within the organization.

8. **Procurement and Supply Chain Information**:

   - Details regarding raw materials, components, and suppliers must be documented.

   - This includes evidence of the quality and reliability of suppliers, especially for critical components.

9. **Local Agent Appointment Document** (if applicable):

   - For foreign manufacturers, an official document appointing a local agent or representative in China is required.

10. **Other Relevant Documents**:

   - This may include a business license, company registration documents, and any previous certifications or regulatory approvals from other markets.

### Conditions for Submission:

- **Language**: All documents must be in Chinese or translated into Chinese, with translations certified where necessary.

- **Authenticity**: All documents must be accurate, complete, and truthful; any discrepancies can lead to rejection of the application.

- **Timelines**: Adhere to submission deadlines and provide any additional information or clarification promptly if requested by the NMPA.

- **Fees**: Be aware of and timely pay any associated fees related to the application and review process.

### Conclusion

It is crucial for manufacturers to ensure proper preparation and organization of all required documents to facilitate a smooth review and approval process. If you need more specific information or assistance regarding any particular document, feel free to ask!

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