Medical equipment is a number of hospitals and clinics must have, and medical equipment is often belong to the high-tech, high-precision equipment, for this medical equipment, then is not every year need to carry out annual review? Below, in order to help you better understand the relevant legal knowledge, Pacific car network editorial organized the relevant content, I hope to help you.
Small medical equipment need annual review and annual inspection
Production license does not require annual review, just the expiration of the license can be changed, just every year there may be a Drug Administration to go to your company to supervise the audit.
Medical equipment classification
Hospitals have medical equipment can be divided into three main categories, namely, diagnostic, therapeutic two categories and medical equipment necessary for the classification of medical equipment of different levels of different requirements.
I, diagnostic equipment class can be divided into the following categories:
Physical diagnostic instruments (thermometers, blood pressure meters, microscopes, audiometers, a variety of physiological recorders, etc.), imaging (X-ray machines, CT scanning, magnetic **** vibration, ultrasound, etc.), analytical instruments (all types of counters, biochemical and immunoassay instruments), electrophysiology (such as electrocardiography, electroencephalogram machine, Electromyography machine, etc.).
The second category of therapeutic equipment can be divided into the following categories:
General surgical instruments, light-guided surgical instruments (fiber endoscopes, laser therapy machines, etc.); auxiliary surgical instruments (such as various anesthesia machines, respiratory machines, extracorporeal circulation, etc.); radiation therapy machinery (such as deep X-ray therapy machine, cobalt 60 therapy machine, gas pedal, gamma knife, various isotope therapy device, etc.); other categories (microwave , hyperbaric oxygen, etc.).
Three, the hospital necessary medical equipment class requirements can be divided into three categories of the following categories:
The first category, the second category and the third category. That is, the first class refers to the routine management is sufficient to ensure its safety, effectiveness of medical devices; the second class refers to its safety, effectiveness should be controlled medical devices; the third class class refers to implanted in the human body, for the support and maintenance of life; the human body has a potential danger and its safety, effectiveness must be strictly controlled medical devices.
It is worth noting that if a medical device contains Class I and Class II, then the medical device is Class II. If a medical device contains Class II and Class III, then the medical device belongs to Class III. By analogy, one can come to the same conclusion.
A variety of simple medical devices for home use, such as thermometers, stethoscopes, blood pressure monitors, etc., with the development of electronic technology, automatic, semi-automatic electronic home medical equipment such as electronic blood pressure monitors, blood glucose testers, electronic thermometers, etc. have come to market.
The above content is related to the answer, medical equipment, each year by the Drug Administration to audit, but for the production license does not need to carry out an annual review, when the time to replace the new on it, for the normal operation of the medical equipment to supervise is very important, if you still have other automotive issues you can consult with the Pacific Automotive Network related.
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