One, Yuyue Medical is a company to provide home medical equipment, medical clinical products and related medical services as the main business.
Two, Sanuo biological is a to the use of biological sensing technology research and development, production and sales of rapid detection of chronic disease products of high-tech enterprises.
Three, Lexin Medical is mainly engaged in the development, production and sales of home medical and health electronic products, as well as the development and operation of Lexin intelligent health cloud platform.
Four, Jiu'an Medical mainly focuses on the research and development, production and sales of home medical and health electronic products as well as the cloud platform system and services, and gradually transformed into an Internet + medical solutions provider.
There are 3 differences between Class III medical devices, Class II medical devices, and Class I medical devices:
One, the three meanings are different
1. Meaning of Class III medical devices: Class III medical devices are the highest level of medical devices, and also medical devices that must be strictly controlled, which are implanted in the human body and Used to support, life-sustaining, potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices.
2. The meaning of Class II medical devices: Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are classified as Class II medical devices.
3. The meaning of a class of medical devices: Class I medical device means that the routine management is sufficient to ensure its safety and effectiveness of medical devices. According to the "supervision and management of medical devices regulations" issued by the state of Article 5, the state will implement the classification and management of medical devices.
Two, three different levels of risk
1. Class III medical device risk level: Class III medical device is a higher risk, need to take special measures to strictly control the management.
2. The degree of risk of Class II medical devices: Class II medical devices is a medium risk, requiring strict control and management.
3. The degree of risk of Class I medical devices: Class I medical devices is a low degree of risk, the implementation of routine management.
Three, the three business regulations are different
1. Class III medical device business regulations
(1) the business premises should be no less than 40 square meters, the use of legal entity branches of the business premises should be no less than 25 square meters (except for the setup of the city across the district); hearing aid business, the business premises should be no less than 25 Square meters; contact lenses and care solutions, business premises should be no less than 10 square meters.
(2) warehouse area should be not less than 30 square meters; the operation of single-use sterile medical devices, the warehouse should be in the same building, the use of the area should be not less than 200 square meters.
(3) quality management, quality institutions should have a nationally recognized, and business products related to the profession, college degree or above, or intermediate or higher technical title in related disciplines. Operation of single-use sterile medical devices, there should also be more than one holding a medical device quality management system internal auditor certificate of the internal auditor and other relevant application conditions.