Instruments and endoscopes: medical ultrasonic instruments and related equipment, medical laser instruments and equipment, medical high-frequency instruments and equipment, physiotherapy rehabilitation equipment, traditional Chinese medicine instruments, medical magnetic vibration equipment, medical X-ray equipment, medical X-ray accessory equipment and parts, medical radionuclide equipment, medical radiation protection products, devices, clinical laboratory and basic equipment and appliances, extracorporeal circulation and blood processing equipment, implant materials and artificial organs, operating rooms, emergency rooms, artificial organs.
Ward nursing equipment and appliances disinfection and sterilization equipment and appliances, medical cold therapy, low temperature and refrigeration equipment and appliances, oral materials, medical sanitary materials and dressings, medical suture materials and adhesives, medical polymer materials and products, interventional equipment.
Medical devices are divided into three categories:
Class one, class two and class three. At present, it is not necessary to apply for a medical device business license to operate a class of products.
The state classifies medical equipment according to the degree of risk:
The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management. Such as: surgical instruments (knives, scissors, pliers, hooks), scraping plates, medical X-rays, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.
The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness. Such as: medical suture needle, sphygmomanometer, thermometer, electrocardiograph, electroencephalograph, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, absorbable suture, condom, etc.
The third category is medical devices with high risks, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness. Such as implantable pacemakers, contact lenses, intraocular lenses, ultrasonic tumor focusing knives, hemodialysis devices, implant devices, vascular stents, comprehensive anesthesia machines, dental implant materials, medical absorbable sutures, intravascular catheters and the like.