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Definition of medical devices

Definition of medical devices

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  • Time of issue:2021-06-24
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(Summary description)In the medical device quality management specifications and related specifications formulated and issued by the International Standard Organization ISO, in the 1980s

Definition of medical devices

(Summary description)In the medical device quality management specifications and related specifications formulated and issued by the International Standard Organization ISO, in the 1980s

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2021-06-24
  • Views:0
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In the medical device quality management specifications and related specifications formulated and issued by the International Standard Organization ISO, in the 1980s. Medical devices are defined. Accordingly, in Article 3 of the regulations on the supervision and administration of medical devices, which came into force on April 1, 2000, China defines medical devices as follows: instruments, equipment, instruments, data or other articles used alone or in combination on the human body, including the required software. Its purpose of use
1. Prevention, diagnosis, treatment, monitoring or remission of diseases;
2. Diagnosis, treatment, monitoring, mitigation or compensation of injury or disability;
3. Research, substitution or regulation of anatomical or physiological processes;
However, these means may participate and play a supporting role. This definition clarifies the use object, use mode, function and product form of medical devices,
4. Pregnancy control. Its main expected effect on human body surface and body is not obtained by means of medication, immunology or metabolism. And it is defined in principle differently from another product group with the same function and use - drugs. The definition of medical devices in conservative industrial management includes not only the categories of medical devices included in the definition of medical devices regulations, but also some hospital auxiliary facilities and instruments that do not directly occur or affect the efficiency of medical care, but also the computer software applied in medical devices. Because it has more commonalities with medical devices in market and management, Therefore, it is included in the definition of medical devices. This definition has been widely used in medical device regulations in China. This definition can be understood as the definition domain of medical device in the sense of regulation adjustment. In theory, to judge whether a product belongs to the category of medical devices, special attention should be paid to the following five points:
1. Whether it is used for human body (the definition of medical device in the United States includes animals and humans)
2. Whether it meets one of the four intended uses specified in the definition.
3. Is there a theoretical basis to support the expected effect (China's traditional Chinese medicine theory has not been generally accepted by all countries at present)
4. Whether there is clinical verification.
5. Whether drugs or metabolism or immunity play a major role. If it meets the above five requirements, it can usually be called a medical device. However, with the rapid development of Biomedical Engineering, some products are difficult to define. For example, at present, there are more and more products combined with medicine and machinery, which is also a direction of the development of medical devices. It is more and more worth studying whether drugs or medical devices play a major role in the positioning of such products. The mode of dual management should be a trend.
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Definition of medical devices
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Time of issue:2021-06-28 17:52:44

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