The first category refers to medical devices that can ensure their safety and effectiveness through daily management. In other words, the risk is low, and the safety and effectiveness of medical devices can be guaranteed through routine management. This kind of medical devices only need related business within the business scope.
The second category refers to medical devices whose safety and effectiveness should be controlled. The risk is moderate and needs strict control and management. Such medical devices need to be filed with relevant departments.
The third category refers to the medical devices that are implanted into the human body to support and maintain life and are potentially dangerous to the human body, and their safety and effectiveness must be strictly controlled. This kind of medical device needs a business license.
Specific medical devices are classified as follows:
Category I: Knives for basic surgery: surgical handles and blades, pure opening belts of skin scalpels, wart peeling knives, The Lancet, shovels, razors, dandruff scrapers, pick knives, front knives, pedicure knife, manicure knives, scalpels, etc.
Category II: 1. General diagnostic instruments (6820): thermometer, sphygmomanometer, 2. Physiotherapy rehabilitation equipment (6826), magnetic therapy equipment, 3. Clinical laboratory analytical instruments (6840), home blood glucose analyzer and test paper, 4. Equipment and appliances for operating room, emergency room and clinic (6854). 6. Medical polymer materials and products (6866): condoms, contraceptive caps, etc.
Category III: A. Disposable sterile medical devices: 1. Disposable sterile syringe. 2. Disposable infusion set. 3. Disposable anesthesia puncture kit. 4. Disposable intravenous infusion needle. 5. Disposable sterile injection needle. 6. Disposable plastic blood bag. 7. Disposable blood sampler. 8. Disposable burette infusion set. B. Orthopedic implants and medical devices: 1. Surgical implants and joint prostheses (except disposable sterile medical instruments, hearing AIDS, contact lenses and nursing solutions, in vitro diagnostic reagents, 6846 implant materials and artificial devices and columns, 6877 interventional devices) and so on.
Extension material: In short, the operator of medical devices should be Lu Qiu.
A class of medical devices can be operated with a business license. The operation of Class II medical devices requires filing, relevant medical personnel information, supplier qualification and business premises of 50 square meters. Licenses are required to operate three types of medical devices, and two quality leaders provide certificates of upstream and downstream channels. The business site is 100 square meter.