AI-MRA

Product registrations in the field of life and health (medical devices/biomedicine) require strict approval and supervision to ensure product safety and efficacy. According to the “Administrative Measures on Medical Device Registration”, according to the normal process, the time required for medical device registration approval is at least 188 working days (that is, about 10 months). The approval and application process is very complicated and complicated, involving extensive data collation and document preparation. Due to the high knowledge barrier, at present, this part of the work is basically manual querying, writing and sorting, which consumes a lot of manpower time. Using a large language model combined with a knowledge base built according to key registration regulations such as NMPA regulations, standards, and guidelines of the National Drug Administration, the system can interact with users to generate the framework and main content of medical device product declaration documents, reduce registration document writing time by 70%, greatly reduce registration costs, and improve enterprise operation efficiency.