The state has a strict classification for medical devices, which is divided into Class I, Class II and Class III.
The first class refers to medical devices whose safety and efficacy can be guaranteed through routine management. That is, the degree of risk is low, the implementation of routine management can ensure its safety and effectiveness of medical devices. This type of medical devices only need to operate within the scope of business related to the business can be.
The second category refers to the safety and effectiveness of medical devices should be controlled. And has a moderate risk, need strict control management. This class of medical devices is required to be filed in the relevant departments.
The third category refers to the implantation of interventions in the human body, used to support, life support, potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices. This type of medical device requires a license to operate.
Specific medical devices are categorized as follows:
Class I: basic surgical knife "scalpel handle and blade, skin blade knife pure trellis tape, wart stripping knife, lancet, spatula, razor, dandruff scraper, picking knife, sharp knife, pedicure knife, manicure knife, scalpel and so on".
The second category: 1. General diagnostic instruments (6820): thermometers, sphygmomanometers, 2. Physiotherapy and rehabilitation equipment (6826), magnetic therapy appliances, 3 clinical testing and analytical instruments (6840), blood glucose analyzers and test strips for home use, 4. Operating room, first aid room, diagnostic and therapeutic room equipment and appliances (6854), small oxygen concentrators for medical use, handheld oxygen generators. 5. Medical hygiene materials and dressings category (6864), medical degreasing cotton, medical degreasing gauze; 6. Medical polymer materials and products category (6866): condoms, contraceptive caps and so on.
The third category: A. Single-use sterile medical devices: 1. Single-use sterile syringes. 2. Single-use infusion sets. 3. Single-use anesthesia puncture kits. 4. Single-use intravenous infusion needles. 5. Single-use sterile hypodermic needles. 6. Single-use plastic blood bags. 7. Single-use blood collectors. 8. Single-use burette-type infusers. b. Orthopedics Implant medical devices: 1. Surgical implants and joint prostheses (except for single-use sterile medical devices, hearing aids, contact lenses and nursing fluids, in vitro diagnostic reagents, 6846 implantable materials and artifacts and vertical organs, 6877 interventional devices) and so on.
Extension of the material: a brief description of the operation of medical equipment to do rushes.
A class of medical devices, for business license can operate. Class II medical device business need to go to the record, provide relevant medical personnel information, supplier qualifications, business premises 50 square feet. Class III medical device business to apply for a license, two quality responsible person, to provide proof of upstream and downstream channels, business premises 100 square.