For NMPA certification, the following standards and technical document requirements are essential:

1. Standards: Devices must comply with relevant national and international standards, such as GB (National Standards of China), ISO, and IEC standards, depending on the device type.

2. Technical Documentation: This includes:

   • Device Description: Detailed information about the device, its intended use, and design.
   • Manufacturing Processes: Description of the manufacturing process, including quality control measures.
   • Safety and Performance Data: Evidence of safety and efficacy, including results from preclinical and clinical trials, if applicable.
   • Risk Management Report: Analysis of potential risks and mitigation strategies.
   • Labeling and Instructions for Use: Clear and compliant labeling materials.
   • Quality Management System: Documentation demonstrating compliance with Good Manufacturing Practices (GMP).

3. Clinical Evaluation Report: Required for Class II and III devices, summarizing clinical data and supporting the device's safety and efficacy.

4. Post-market Surveillance Plan: A plan detailing how the manufacturer will monitor device performance after market entry.

Would you like to explore any specific standards or documentation in greater detail?

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