Classification of medical devices:?
The first category refers to, through routine management is sufficient to ensure the safety and effectiveness of medical devices.
Including basic surgical knives "scalpel handle and blade, skin blade knife, wart removal knife, lancet, spatula, razor, dandruff scraper, pick knife, sharp knife, pedicure knife, manicure knife, scalpel, etc."
The second category refers to the safety, effectiveness of medical devices should be controlled.
Including general diagnostic instruments: thermometers, sphygmomanometers, physical therapy and rehabilitation equipment: magnetic therapy appliances, clinical testing and analytical instruments: blood glucose analyzers and test strips for home use, operating room, emergency room, diagnostic and treatment room equipment and appliances: medical oxygen concentrator, portable oxygen generator, medical hygiene materials and dressings: cotton wool, cotton pads, cotton gauze, polymer materials and products for medical use. products: condoms, contraceptive caps, and so on.
The third category refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices.
Including single-use sterile medical devices: single-use sterile syringes, single-use infusion sets, single-use blood transfusion sets, single-use anesthesia puncture kits, single-use intravenous needles, single-use sterile injection needles, single-use plastic blood bags, single-use blood collectors, single-use burette-type infusion sets. Orthopedic implants medical devices: surgical implants joint prosthesis (except for single-use sterile medical devices, hearing aids, contact lenses and care fluids, in vitro diagnostic reagents, implantable materials and artificial organs, interventional devices)
Extended information: Scope of the medical device license: 1, the operation of the second and third class of medical device products of legal entities, unincorporated units and legal entities set up by the branches Should apply for "medical device license". State Food and Drug Administration, except as otherwise provided. 2, financial leasing of medical equipment products, medical equipment business enterprises or medical device manufacturers in the enterprise "Medical Device Business Enterprise License" or "Medical Device Manufacturer License" set out in places other than the registered address to set up business premises for the operation of medical equipment products, as well as medical device manufacturers to sell self-produced products outside the scope of the medical device products, should apply for "Medical Device Business Enterprise License". Medical Device Business Enterprise License". 3, unincorporated units applying for "Medical Device License", is limited to the operation of Class II medical device products or Class III medical device products in contact lenses and care solution. Reference: