Instruments and endoscopic equipment, medical ultrasound instruments and related equipment, medical laser instruments and equipment, medical high-frequency instruments and equipment, physical therapy and rehabilitation equipment, traditional Chinese medicine instruments, medical magnetic **** vibration equipment, medical X-ray equipment, medical X-ray accessory equipment and components, medical high-energy ray equipment, medical nuclide equipment, medical ray protection supplies, devices, clinical test and analysis instruments, medical laboratory and basic equipment. Apparatus, extracorporeal circulation and blood processing equipment, implantable materials and artificial organs, operating room, emergency room, diagnostic and treatment room equipment and appliances stomatology equipment and appliances.
Ward care equipment and appliances disinfection and sterilization equipment and appliances, medical cold therapy, low temperature, cold storage equipment and appliances stomatology materials, medical hygiene materials and dressings medical suture materials and adhesives, medical polymer materials and products interventional devices.
Medical equipment is divided into three categories:
Class I, Class II, Class III, currently operating a class of products are not required to apply for a medical device license.
The state of medical devices in accordance with the degree of risk of implementation of the classification:
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices. Such as: surgical instruments (knife, scissors, pliers, tweezers, hooks), scraping board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags and so on.
The second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalograms, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms and so on.
The third category is a higher risk, need to take special measures to strictly control the management of medical devices to ensure their safety and effectiveness. Such as: implantable cardiac pacemakers, corneal contact lenses, artificial crystals, ultrasound tumor focusing knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machine, dental implant materials, medical absorbable sutures, intravascular catheters.