State Drug Administration Enhances Registration Guidance for AI and Biomaterials Products under "Key Project List and Leading Role" Initiative
3 week ago / Read about 0 minute
Author:小编   

The State Drug Administration has recently unveiled a suite of measures designed to streamline supervision across the entire product lifecycle and foster the innovative development of high-end medical devices. For pioneering domestic and internationally leading products with substantial clinical value, the administration will persist in executing special innovative review processes, refining review procedures, and reinforcing technical guidance. Moreover, changes in the registration of high-end innovative medical devices will be scrutinized under innovative procedures to expedite the market introduction of devices that align with industrial policies. Additionally, the administration will bolster registration guidance for products in domains such as artificial intelligence and biomaterials, facilitate the development of support policies for brain-computer interface medical devices, and explore specific conditions for conditional approval.