Medical class I class II class III business scope

The first class of medical devices include: through routine management is sufficient to ensure its safety, effectiveness of medical devices. Do not need to apply for the record and qualification of the second class refers to its safety, effectiveness should be controlled medical devices. Must apply to the relevant departments for the record the third category refers to, implanted in the human body; used to support, maintain life; the human body has a potential danger to its safety, effectiveness must be strictly controlled medical devices. Must obtain the "medical device business enterprise qualification". Class II medical devices include: 6801 basic surgical instruments; 6803 neurosurgical instruments; 6804 ophthalmic surgical instruments; 6806 stomatological surgical instruments; 6807 thoracic cardiovascular surgical instruments.

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. Medical devices include medical equipment and medical consumables.

From the business license has the following differences:

1, a class does not need a license and filing can be sold, only need to add the business license on the sale of medical equipment on the line.

2, the second class of the need for medical equipment business record certificate.

3, Class III only need to apply for a medical device license.

Legal basis:

"Regulations on the Administration of Medical Institutions"

Article 6: The health administrative departments of the local people's governments at or above the county level shall, in accordance with the population of the administrative region, medical resources, medical needs and the distribution of the existing health care institutions, formulate a plan for the setting up of health care institutions in the administrative region.

Organs, enterprises and institutions can set up medical institutions in accordance with the needs, and included in the local medical institutions set up planning.

Article 8 The setting up of medical institutions shall be in accordance with the planning for the establishment of medical institutions and the basic standards for medical institutions.

Basic standards for medical institutions by the State Council administrative department of health.

Article IX units or individuals to set up medical institutions must be examined and approved by the health administrative department of the local people's government at or above the county level, and obtain approval to set up medical institutions.

Article 28 Medical institutions shall not use non-health technicians to engage in medical and health technology.

Article 36 Medical institutions must strengthen the management of drugs in accordance with the laws and regulations on drug management.

Article 40 The health administrative departments of the people's governments at or above the county level shall exercise the following supervisory and management powers:

(1) To be responsible for the approval of the setting up of medical institutions and the registration and verification of their practice;

(2) To carry out inspections and guidance for the practice of medical institutions;

(3) To be responsible for organizing the evaluation of medical institutions;

(4) To impose penalties for violations of these regulations. (d) To impose penalties for violations of these regulations.