The NMPA (National Medical Products Administration) certification of medical devices requires the submission of detailed technical documents to ensure the safety, effectiveness and compliance with relevant regulatory standards of the product. The following are some aspects of the technical documentation requirements required for NMPA certification in general:
Product Technical Specifications: Provide detailed product technical specifications, including information on the product's design, use, indications, and expected effects.
Performance Test Report: Provide a product performance report that has been tested by a qualified laboratory to ensure that the performance of the product meets the corresponding standards.
Manufacturing process: Provide a detailed description of the manufacturing process, including the selection and procurement of raw materials, production process, quality control process, etc.
Quality Control System: Provide quality control system documents to ensure that the products are subject to effective quality control throughout the production process.
Translation of technical documents: If the original technical documents are not in Chinese, a Chinese translation is usually required.
Product Identification and Instructions: Provide information such as product identification, instruction manuals, and labels to ensure that users can use the product correctly.
Adverse Event Report: Provide adverse event reports after the product is launched in other markets, as well as corresponding risk analysis and risk management measures.
Qualification of manufacturing enterprises: Provide GMP (good manufacturing practice) certificates of manufacturing enterprises to ensure that the manufacturing process meets the standards.
Compliance of raw materials: Provide proof of compliance of raw materials to ensure that the raw materials used meet the relevant regulatory standards.
Technical Evaluation: Technical documentation may be evaluated by a certification body to ensure its integrity and compliance.