Medical device products of various categories and varieties, from the division of the major categories alone up to more than 30 categories, while its varieties are more than 3,000 kinds, specifications in more than 10,000 kinds. In order to effectively supervise and manage medical equipment products, the state of these products to implement the first, second and third class classification management. The principles of these three categories and the main categories they contain are as follows.
(A) the first class
Through routine management is sufficient to ensure the safety and effectiveness of medical devices. Such as most surgical instruments, stethoscopes, medical x-ray film, medical x-ray protection, automatic electrophoresis, medical centrifuges, slicers, dental chairs, boiling sterilizers, gauze bandages, elastic bandages, ointment, band-aids, cupping device, surgical gowns, surgical caps, masks, urinary collection bags.
(B) the second category
For its safety, effectiveness should be controlled medical devices. Such as thermometers, sphygmomanometers, hearing aids, oxygen concentrators, condoms, acupuncture needles, electrocardiographic diagnostic instruments, non-invasive monitoring instruments, optical endoscopes, portable ultrasound diagnostic instruments, automatic biochemical analyzers, constant temperature incubators, dental comprehensive treatment instrument, medical cotton wool, medical cotton wool, medical gauze, etc..
(C) the third category
for implantation in the human body or to support life-sustaining, potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripter, patient invasive monitoring systems, artificial crystals, invasive endoscopes, ultrasound scalpels, color ultrasound imaging equipment, laser surgical equipment, high-frequency scalpels, microwave therapy, medical nuclear magnetic **** vibration imaging equipment, x-ray therapeutic equipment, more than 200mA x-ray machine, medical high-energy equipment, artificial heart-lung machine, internal fixation devices, artificial heart valves, artificial kidney, respiratory anesthesia equipment, single-use sterile syringes, single-use infusion sets, blood transfusion, CT equipment, etc..