The state has a strict classification for medical devices, which are divided into Class I, Class II and Class III.
The first class refers to the routine management of medical devices to ensure their safety and effectiveness. 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 intervention 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, wart removal knife, lancet, spatula, razor, dandruff scraper, picking knife, sharp knife, pedicure knife, manicure knife, dissecting knife, etc.".
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 artificial organs, 6877 interventional devices) and so on.
Extended material: a brief description of the requirements for operating medical devices.
A class of medical devices, for business license can operate.
The second class of medical equipment business need to go to the record, provide relevant medical personnel information, supplier qualifications, business premises 50 square feet.
The third class of medical equipment business to apply for a license, two quality person in charge, to provide proof of upstream and downstream channels, the business site 100 square feet.