Medical device classification

Medical equipment refers only to equipment that assists human rehabilitation either directly or indirectly, including equipment, appliances, and instruments. The main method of using medical devices is to physically assist the human body in rehabilitation. Different from the rehabilitation of taking medicine, reagents, surgery and other means.

 

The classification of medical devices can be divided into the following categories: First, they are mainly medical beds and beds, including products such as infusion chairs, waiting chairs, and nursing cars. These medical devices can be effective through routine supervision. Safe quality products.

 

Class II medical devices:

 

The basic definition of Class II medical devices is medical devices whose safety and effectiveness should be controlled. In addition to Class B medical devices, biochemical instruments, and microscopes and X-ray film machines, some surgical instruments also belong to Class II. Medical devices, such as scalpels.

 

Three types of medical devices:

 

This is the most stringent type of medical device managed by the state, because its main purpose is to help the human body recover by implanting it into the body, or to support the patient's life. Because such medical devices are potentially dangerous to the human body, the state has very strict regulations for the approval of this medical device manufacturer.

 

Medical device manufacturer registration procedures have different registration requirements based on the product classification. The registration of a type of medical device is the easiest, as long as it is filed with the local drug regulatory bureau and it has two or more medical departments. Professional graduates will do. However, the second-class and third-class medical devices have more stringent requirements, because the details are cumbersome, and no examples will be given here.

 

Since 2010, the state has paid close attention to the medical cause. From the problem of people's livelihood to medical infrastructure, it has made great policy support. In the past year or two, the state has also paid great attention to the production of local medical devices and encouraged enterprises Following the technology research and development line, we are also calling on and encouraging major hospitals to use domestic medical equipment.