The required document content for China NMPA certification application
分类:行业新闻 发布时间:2024-09-25 14:35:26
Ensuring all documentation is complete, accurate, and well-organized is crucial for a successful application.

For NMPA certification application in China, the required document content typically includes:

  1. Application Form: Completed NMPA application form with basic information about the manufacturer and the medical device.

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

  3. Quality Management System Documentation: Evidence of compliance with ISO 13485 or relevant quality management standards, including quality manual and procedures.

  4. Risk Management Report: A report outlining the risk management process according to ISO 14971, detailing identified risks and mitigation strategies.

  5. Testing and Evaluation Data:

    • Preclinical Testing Reports: Results from safety and performance testing, including biocompatibility, electrical safety, etc.
    • Clinical Evaluation Reports: Data supporting the safety and efficacy of the device, including clinical trial results if applicable.
  6. Manufacturing Information: Details about the manufacturing process, including facility information and any subcontractors involved.

  7. Labeling and Instructions for Use: Samples of labeling, packaging, and user instructions that comply with NMPA regulations.

  8. Technical File: A comprehensive file that consolidates all the above documents and supporting materials.

  9. Declaration of Conformity: A document declaring compliance with applicable regulations and standards.

  10. Other Supporting Documents: Any additional documents required by the NMPA, such as distributor agreements or relevant certifications.

Ensuring all documentation is complete, accurate, and well-organized is crucial for a successful application.

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