Categorization of medical devices:?
Class I refers to medical devices whose safety and efficacy can be ensured through routine management.
Including basic surgical knife "scalpel handle and blade, skin blade knife, wart removal knife, lancet, spatula, razor, dander 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, single-use anesthesia puncture kits, single-use intravenous needles, single-use sterile injector needles, single-use plastic blood bags, single-use blood collectors, single-use burette-type infusion set. 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)
Expanded Information:
Medical device license scope:
1, the operation of the second and third class of medical equipment products, legal entities, unincorporated units and legal entities set up by the branch should apply for the "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 up outside the registered address of the place of business operating medical device products, as well as medical device manufacturers to sell self-produced products outside the scope of 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 nursing fluids.
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