The technical file requirements for NMPA certification of multi-parameter monitors in China typically include comprehensive documentation to demonstrate the safety, performance, and quality of the device. Here are the key components usually required:

1. Device Description and Specifications:

   • Detailed description of the multi-parameter monitor, including its intended use, design features, and specifications (e.g., dimensions, weight, materials).

2. Design Drawings and Diagrams:

   • Schematics, diagrams, and drawings illustrating the design and construction of the device.

3. Risk Management File:

   • Risk analysis according to ISO 14971, outlining identified hazards, risk assessment, and risk control measures implemented to mitigate risks.

4. Verification and Validation Data:

   • Evidence demonstrating that the device meets specified requirements and performs as intended under normal conditions and foreseeable misuse. This includes:
     • Verification testing (e.g., mechanical, electrical, software verification).
     • Validation testing (e.g., performance testing, reliability testing).

5. Clinical Evaluation Data (if applicable):

   • Clinical evaluation report demonstrating the safety and performance of the device based on clinical data, relevant literature, and/or clinical trials conducted in accordance with applicable standards.

6. Labeling and Instructions for Use:

   • Labeling content in Chinese, including product labeling, user manual, and packaging information. This should include clear instructions for safe and effective use of the device.

7. Software Information (if applicable):

   • Description of software used in the multi-parameter monitor, including software version, architecture, functions, and validation and verification activities.

8. Biocompatibility Testing:

   • Documentation demonstrating compliance with biocompatibility requirements specified in ISO 10993 or equivalent standards.

9. Electromagnetic Compatibility (EMC) Testing:

   • EMC test reports demonstrating compliance with applicable standards to ensure electromagnetic compatibility of the device in its intended environment.

10. Manufacturing Information:

    • Details about the manufacturing process, quality control procedures, and documentation demonstrating compliance with Good Manufacturing Practice (GMP) requirements.

11. Summary Technical Documentation:

    • A summary document providing an overview of the technical file contents and key findings related to device safety and performance.

12. Quality Management System (QMS) Documentation:

    • Evidence of compliance with ISO 13485 or an equivalent quality management system, including certificates and audit reports.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn