The technical file requirements for obtaining an NMPA (National Medical Products Administration) registration certificate for multi-parameter monitors in China are comprehensive and must demonstrate compliance with regulatory standards. Here are the key components typically required:

1. Device Description and Specifications

• Device Description: Detailed description of the multi-parameter monitor, including its intended use, design features, and specifications (e.g., dimensions, weight).
• Technical Specifications: Comprehensive list of technical specifications, such as measurement parameters, accuracy requirements, and operational characteristics.

2. Design and Manufacturing Information

• Design Drawings and Diagrams: Schematic diagrams, engineering drawings, and layout plans of the device components and assembly.
• Manufacturing Processes: Description of manufacturing processes, materials used, and quality control measures to ensure consistency and quality during production.

3. Risk Management File

• Risk Analysis: Documentation of risk management activities, including hazard identification, risk assessment, and risk control measures implemented to mitigate identified risks.
• Risk Management Report: Summary report outlining the overall risk management process and demonstrating compliance with ISO 14971 or equivalent standards.

4. Verification and Validation Data

• Verification Testing: Results and reports from verification testing conducted to demonstrate that the device meets specified design inputs and requirements.
• Validation Testing: Results and reports from validation testing to confirm that the device performs safely and effectively in its intended clinical use environment.

5. Clinical Evaluation Data

• Clinical Evaluation Report: If clinical evaluation is required based on device classification, include a report summarizing clinical data and studies conducted to evaluate the device’s safety, performance, and efficacy.
• Clinical Data: Patient data, study protocols, results, and conclusions from clinical investigations, if applicable, to support the device’s clinical claims.

6. Labeling and Instructions for Use

• Labeling: Samples of labels affixed to the device, packaging, and instructions for use (IFU) in Chinese.
• IFU: Detailed instructions for use in Chinese, including device setup, operation, maintenance, precautions, and troubleshooting.

7. Software Information (if applicable)

• Software Description: Description of the software architecture, functionalities, and algorithms used in the device.
• Software Validation: Validation data and reports demonstrating the software’s performance, reliability, and safety according to applicable standards.

8. Biocompatibility Testing (if applicable)

• Biocompatibility Report: Results and reports from biocompatibility testing conducted according to ISO 10993 or equivalent standards, demonstrating the device’s compatibility with biological systems.

9. Quality Management System (QMS) Documentation

• QMS Certificate: Copy of the certificate demonstrating compliance with ISO 13485 or an equivalent quality management system standard.
• QMS Documentation: Overview of the quality management system, including procedures, processes, and controls implemented to ensure consistent device quality and regulatory compliance.

Contact Us：

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