Medical devices is an important part of the pharmacy management and regulations for licensed pharmacists, the following compilation of a class, two, three medical device distinction concept, for unfamiliar with a class, two, three types of related knowledge can strengthen the concept of medical device category distinction.
I. Classification of medical devices
The first category refers to the regular management of medical devices sufficient to ensure their safety and effectiveness.
The second category refers to the safety and effectiveness of the medical device should be controlled.
The third category refers to the implantation of the human body to support, maintain life; the human body has a potential risk, the safety and effectiveness of the medical device must be strictly controlled.
Second, the scope of medical equipment licensing
1. The operation of Class II and Class III medical device products, legal entities, unincorporated units and branches of legal entities should apply for "medical device business license. Except as otherwise provided by the State Food and Drug Administration.
2. Financing leases medical device products, medical device 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 to operate medical device products, as well as medical device manufacturers to sell self-produced products outside the scope of medical devices, should apply for "medical device business enterprise License".
3. Unincorporated units to apply for "medical device business enterprise license", only the second class medical device registered products or third class medical device products in the contact lens and care solution.
Third, a class, class II, class III medical device difference
Class I, Class II and Class III terminology management categories, see the medical device supervision and management regulations have relevant provisions. Management from low to high. Medical devices, refers to instruments, equipment, apparatus, materials or other items used in the human body alone or in combination, including the required software; its use on the human body surface and in vivo is not obtained by means of pharmacology, immunology or metabolism, but may have these means involved and play a role in the auxiliary; its use is intended to achieve the following intended purposes:
(1) Prevention, diagnosis, treatment, monitoring, and mitigation of disease.
(2) Diagnosis, treatment, monitoring, mitigation, and compensation for injury or disability.
(3) The study, replacement, and regulation of anatomical or physiological processes.
(4) Pregnancy control. Medical devices are divided into three categories.
Medical device products have a wide range of categories and varieties, divided into more than 30 categories from the major categories alone, while their varieties are more than 3,000, with specifications in more than 10,000 kinds. In order to effectively supervise and manage medical equipment products, the state of these products to implement one, two, three categories of classification management. These three categories are divided into the principles and contains the main categories are as follows:
① The first category
For the routine management of medical devices to ensure their safety and effectiveness. Such as most surgical instruments, stethoscopes, medical x-ray film, medical x-ray protection devices, automatic electrophoresis instrument, medical centrifuges, slicers, dental chairs, boiling sterilizers, gauze bandages, elastic bandages, ointment, band-aids, cupping devices, surgical gowns, surgical caps, masks, urine bags, etc.
② the second category
for its safety and effectiveness should be controlled medical devices. Such as thermometers, sphygmomanometers, hearing aids, oxygen machines, condoms, acupuncture needles, electrocardiographic diagnostic equipment, non-invasive monitoring instruments, optical endoscopes, portable ultrasound diagnostic instruments, automatic biochemical analyzers, constant temperature incubators, dental comprehensive treatment instrument, medical skim cotton, medical skim gauze, etc.
③Third category
Used for implantation into the human body or to support life support, 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, invasive patient monitoring systems, IOLs, invasive endoscopes, ultrasonic scalpels, color ultrasound imaging equipment, laser surgery equipment, high-frequency electric knife, microwave therapies, medical magnetic resonance imaging equipment, x-ray therapy equipment, x-ray machines above 200mA, medical high-energy equipment, artificial heart and lung machines, internal fixation equipment, artificial heart valves, artificial kidneys Respiratory anesthesia equipment, single-use sterile syringes, single-use infusion sets, blood transfusion sets, CT equipment, etc.