What is a medical device
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software.
The hospital has medical equipment can be divided into three categories, namely, diagnostic, therapeutic two categories and medical equipment necessary for the classification of medical equipment of different requirements of each class.
Class I refers to the routine management is sufficient to ensure its safety, effectiveness of medical devices; Class II refers to its safety, effectiveness should be controlled medical devices; Class III class refers to the implantation of the body, for the support and maintenance of life; on the human body has a potential danger and its safety, effectiveness must be strictly controlled medical devices.