Medical devices refer to instruments, devices, instruments, in vitro diagnostic reagents and calibrators, materials, and other similar or related items that are used directly or indirectly in the human body, including the required computer software. Its main purpose is to diagnose, prevent, monitor, treat or alleviate the disease; treatment, mitigation, functional compensation of the injury; and support or maintenance of life. According to the structure and intended use of medical device products, China implements different methods of medical device management according to risk level, implements registration license for high-risk medical devices, and implements listing management for low-risk medical devices.
Based on the intended use of medical devices, the vast majority of medical devices are used by qualified and trained medical personnel within the medical facility. According to Article 10 of the Regulations on the Management of Medical Devices and Labels, the instructions for medical devices used by consumers themselves shall have special instructions for safe use.