The Provisions is formulated in accordance with the Drug Administration Law of the People's Republic of China, Regulations for Implementation of the Drug Administration Law of the People's Republic of China, and Regulations for Supervision and Administration of Medical Devices, etc., to strengthen the supervision and inspection of drugs and medical devices and reinforce the prevention and control of safety risks.

The unannounced inspection of drugs and medical devices herein refers to the supervision and inspection conducted in the process of research, development, manufacture, distribution and use of drugs and medical devices by the food and drug regulatory departments without advance notice.