Product Design and Performance Specifications: Provide detailed product design descriptions, including structure, function, and features. Describe the intended use of the product, performance parameters, and relevance to other devices.
Manufacturing Processes and Processes: Provide detailed descriptions of manufacturing processes and processes to ensure that the production process of the product can be stable, controllable, and compliant with relevant regulations.
Quality Control System: Provide quality control system documents, including the quality control plan, process control and quality inspection steps formulated and executed. Ensure that the quality of the products can meet the relevant standards and regulations.
Biocompatibility & Material Information: Provides details of the materials that come into contact with the product, as well as the results of biocompatibility testing. Ensure the material safety and biocompatibility of the product.
Electromagnetic Compatibility (EMC) and Electrical Safety: If the product contains electronic components, test reports and technical documents related to electromagnetic compatibility and electrical safety are required to ensure the safety and reliability of the product.
Performance Testing and Validation: Provide product performance testing and validation reports that have been tested by qualified laboratories. This may include a variety of tests for performance, safety, and effectiveness.
Risk Analysis and Risk Management: Provide product-specific risk analysis and risk management plans. Ensure the identification, assessment and control of potential risks.
Instruction Manual: Provide clear and accurate instruction manuals, including safe use of the product, maintenance guidelines, and warning information.
Overall Completeness of Technical Documentation: Ensure that the technical documentation is complete and contains all necessary information for a comprehensive evaluation of the product by the NMPA.