When applying for NMPA certification for medical devices in China, manufacturers must provide a comprehensive set of documents that demonstrate compliance with relevant regulations and standards. The specific documents required can vary depending on the classification of the medical device (Class I, II, or III), but the following list outlines the common documents required for the application process:

General Document Requirements

1. Application Form

   • A completed application form specific to the NMPA, detailing the manufacturer and device information.

2. Business License

   • A copy of the manufacturer's business license, proving that the company is legally registered in China or has the right to conduct business there.

3. Product Information

   • Detailed information about the medical device, including its name, model, specifications, intended use, and description of features.

4. Quality Management System Documentation

   • This includes evidence of compliance with relevant QMS standards (e.g., ISO 13485).
   • A copy of the quality manual and relevant standard operating procedures (SOPs).

Technical Documentation

1. Device Design and Development Documents

   • Design history file, including design specifications, design verification and validation results, and the device's intended use.

2. Risk Management File

   • Documentation of risk assessment and management in accordance with ISO 14971.

3. Manufacturing Process Description

   • Information about the manufacturing processes, controls, and environment, ensuring the device is produced under controlled conditions.

4. Technical Requirement Compliance

   • Proof of compliance with national standards (GB standards) and any applicable international standards (ISO, IEC).

Testing Documentation

1. Testing Reports
   • Results from relevant performance testing, safety testing, and evaluations, including:
     • Biocompatibility testing reports.
     • Electrical safety and electromagnetic compatibility (EMC) testing results.
     • Any other relevant pre-clinical test reports.

Clinical Evidence (For Class II and III Devices)

1. Clinical Evaluation Report
   • A comprehensive report summarizing the clinical data and literature that supports the device's safety and effectiveness.
   • For devices requiring clinical trials, trial protocols, ethical approvals, and final trial reports must be included.

Labeling and Packaging

1. Product Labeling
   • Samples of the product label, including instructions for use (IFU), packaging, and labeling materials compliant with NMPA regulations.

Administrative Documents

1. Certificate of Free Sale (CFS)

   • A document providing evidence that the device is legally sold in the manufacturer’s home country or other markets.

2. Authorization Letter

   • If applicable, a letter from the manufacturer’s legal representative or authorized agent in China, granting authority to submit the application on their behalf.

3. Adverse Event Reporting Procedures

   • Documentation of procedures for reporting adverse events, including post-market surveillance plans.

Additional Documents (If Applicable)

1. Device History Record

   • A comprehensive summary of the manufacture and supply of the device, detailing batches, lot numbers, etc.

2. Post-Market Surveillance Plans

   • Plans that outline how the manufacturer will monitor the device post-launch for safety and efficacy.

Conclusion

While this list provides an overview of the typical documents required for NMPA certification, specific situations may lead to varying requirements based on the nature of the device and associated risks. It's advisable to consult directly with the NMPA or regulatory experts to ensure all necessary documentation is prepared accurately and comprehensively for your specific product.

If you have further questions about preparing your application or need information about a particular type of device, feel free to reach out!

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