Medical devices are various equipment, instruments, apparatus, and materials used in medical activities for the prevention, diagnosis, treatment, monitoring, and mitigation of diseases, as well as for the maintenance of the structure and function of the human body. They examine, diagnose, treat and rehabilitate the human body through physical, chemical and biological principles or methods.
Medical devices are widely used in places and environments such as clinical care, laboratory testing, rehabilitation, oral health care, first aid and rescue, and home care. Different types of medical devices have their own specific functions and uses, including but not limited to sphygmomanometers, thermometers, electrocardiographs, respiratory machines, scalpels, microscopes, CT scanners, dental equipment, wheelchairs, infusion sets, and more.
The development of medical devices is closely linked to medical science, providing physicians with more accurate and effective tools to diagnose diseases, monitor patient conditions, perform surgeries and treatments, and more. At the same time, medical devices also bear the important responsibility of ensuring patient safety and improving the quality of medical care. Therefore, the research and development, production, sale and use of medical devices need to strictly comply with relevant regulations and standards to ensure their safety, effectiveness and reliability.
In China, the registration and supervision and management of medical devices is the responsibility of the National Drug Administration (NMPA), which has established the Classification Catalog of Medical Devices as well as other relevant regulations and standards to regulate and control the safety, quality, and efficacy of medical devices in order to protect public health and safety. Users should follow the instructions of a physician or professional when using a medical device and pay attention to proper operation and maintenance to ensure its safe and effective functioning.