What is a medical device
2023-03-17 16:30
Medical instruments refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related articles, including required computer software, which are directly or indirectly used in human body.
Medical devices include medical equipment and medical consumables.
The benefits are obtained primarily through physical means, not through pharmacological, immunological, or metabolic means, or they are involved but only in ancillary roles.
The purpose is to diagnose, prevent, monitor, treat or alleviate the disease; Diagnosis, monitoring, treatment, remission or functional compensation of injury; The examination, replacement, regulation or support of physiological structures or processes; Life support or maintenance; Pregnancy control; To provide information for medical or diagnostic purposes through examination of samples from human bodies.
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Medical instruments refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related articles, including required computer software, which are directly or indirectly used in human body.
History of medical device development
Medical device industry involves medicine, machinery, electronics, plastics and other industries, is a multidisciplinary, knowledge-intensive, capital-intensive high-tech industry. The basic characteristics of high-tech medical equipment are digitalization and computerization, and it is the crystallization of modern high technology of multi-disciplines and cross-fields. Its products have high technology content and high profit, so it is the top point of competition among major scientific and technological countries and large international companies, and the threshold of entry is high. Even in the industry overall gross profit rate is low, investment is not high sub-industries will continue to have higher technology products, and from which some enterprises with strong profitability. Therefore, the overall trend of the industry is high investment, high yield.
State Food and Drug Administration meeting: strict inspection of medical equipment network sales
Recently, the State Food and Drug Administration held a chamber of commerce for the management of medical device network trading risk.
$69 million from just two equipment suppliers
Under the influence of the policy, the thinking of the hospital has changed, and the supply, processing and distribution mode of consumables and reagents have also been reversed. The circulation market is being washed away by the big waves.