Classification of medical devices:
Class I refers to medical devices whose safety and effectiveness are sufficiently ensured through routine management.
Including basic surgical knife "scalpel handle and blade, skin blade knife, wart removal knife, lancet, spatula, shaving knife, dander scraper, pick knife, sharp knife, pedicure knife, manicure knife, scalpel, etc.".
Class II refers to, its safety, effectiveness should be controlled medical devices.
Including general diagnostic instruments: thermometers, sphygmomanometers, physical therapy and rehabilitation equipment: magnetic therapy appliances, clinical testing and analysis instruments: home blood glucose analyzers and test strips, 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 pads, medical degreasing gauze, polymer materials and products: condoms, caps and so on. The third category refers to, implanted in the human body.
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 infusion needles, single-use sterile injection needles, single-use plastic blood bags, single-use blood collectors, single-use burette-type transfusion sets. Orthopedic implants medical devices: surgical implants joint prosthesis (except for single-use sterile medical devices, hearing aids, contact lenses and nursing fluids, in vitro diagnostic reagents, implantable materials and artificial organs, interventional devices), etc.