Registration and Review of Artificial Intelligence (AI) Medical Devices in China
Artificial Intelligence (AI) has the potential to revolutionize the healthcare industry by improving the accuracy, efficiency, and speed of diagnosis and treatment. However, the development and deployment of AI medical devices also pose significant Regulatory challenges. In response, China's National Medical Products Administration (NMPA) has issued guidelines for registering and reviewing AI medical devices. This review will provide a comprehensive overview of these guidelines, their implications, and their potential impact on AI medical devices in China.