A collection of Class I, Class II and Class III medical devices!
In the process of handling the medical device business license, some enterprise bosses do not know what kind of license to handle when operating the first, second and third categories of medical devices. They always think that they are going to handle the medical device business license. In fact, it is wrong!
What is a medical device?
Medical devices refer to the instruments, equipment, appliances, materials or other articles used independently or in combination for human body, including the required software. It is used for the following intended purposes:
(1) Prevention, diagnosis, treatment, monitoring and mitigation of diseases;
(2) Diagnosis, treatment, monitoring, mitigation and compensation of injuries or disabilities;
(3) Research, replacement and regulation of anatomical or physiological processes;
(4) Pregnancy control.
Classification of medical devices
According to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, the state implements classified management of medical devices according to the degree of risk.
The first category refers to medical devices whose safety and effectiveness can be guaranteed through routine management. The first category is the medical devices with low risk, and the implementation of routine management can ensure their safety and effectiveness.
The second category refers to the medical devices whose safety and effectiveness should be controlled. The second category is the medical devices with moderate risks that need strict control and management to ensure their safety and effectiveness.
The third category refers to the medical devices implanted into the human body to support and maintain life, which are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled.