The submission requirements for documents applying for China NMPA (National Medical Products Administration) certification involve a comprehensive set of documents and information. Here’s a detailed list of the key requirements:

1. Application Form

Completed Form: Fill out the NMPA application form accurately. This form includes basic information about the device, manufacturer, and the intended use.

2. Technical Documents

Device Description: Detailed description of the medical device, including its design, intended use, and function.

Specifications and Performance Data: Technical specifications and performance characteristics of the device, including any compliance with relevant standards.

Manufacturing Information: Information about the manufacturing process, including facilities, equipment, and quality control procedures.

Risk Management: Documentation of risk analysis and management measures according to relevant standards.

3. Clinical Data

Clinical Trials: Results from clinical trials demonstrating the safety and efficacy of the device. For high-risk devices, clinical trials conducted in China may be required.

Clinical Evaluation Reports: Detailed reports summarizing clinical data and its relevance to the device’s performance and safety.

4. Testing and Compliance Data

Laboratory Test Reports: Results from testing conducted at accredited labs, including tests for safety, performance, and biocompatibility.

Standards Compliance: Evidence of compliance with relevant Chinese and international standards, such as GB standards and ISO certifications.

5. Labeling and Instructions

Product Labeling: Labels must be in Chinese and include necessary information such as product name, indications for use, warnings, and usage instructions.

User Manuals: Detailed user manuals or instructions for use, also in Chinese, outlining how the device should be used, including any safety precautions.

6. Quality Management System Documentation

GMP Compliance: Documentation demonstrating compliance with Good Manufacturing Practices (GMP). This may include quality management system certification, such as ISO 13485.

7. Company Information

Manufacturer Details: Information about the manufacturer, including business license, company profile, and any relevant certifications.

Authorized Representative: If applicable, details of the authorized representative in China who is responsible for regulatory affairs.

8. Regulatory History

Previous Registrations: Information about any previous registrations or certifications for the device in other countries, if applicable.

Regulatory Compliance History: Any history of compliance issues or regulatory actions taken against the device or manufacturer.

9. Submission Process

Online Submission: Documents must be submitted through the NMPA’s online registration system. Ensure all documents are uploaded in the required formats and adhere to the system’s guidelines.

Physical Copies: Some documents may need to be submitted in physical form, especially if required by the NMPA or for certain types of devices.

10. Additional Requirements

Translation: All documents must be translated into Chinese. Ensure translations are accurate and, if required, certified or notarized.

Fees: Payment of any required application fees or charges associated with the certification process.

Conclusion

Submitting documents for NMPA certification involves preparing a detailed and accurate set of documents, including technical data, clinical evidence, and quality management information. Adhering to the specific submission requirements and ensuring compliance with all regulatory guidelines is crucial for a successful certification process and entry into the Chinese market.

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