What are medical devices? What are the common misunderstandings of medical devices?


Medical devices refer to instruments, equipment, in vitro diagnostic reagents and calibrators, and other related articles used in human body including required computer software. Its effectiveness is mainly obtained by physical means instead of pharmacology, immunology or metabolism.

What are the common misunderstandings about medical devices?

Misunderstanding 1

Medical devices are high-risk.

Medical devices can only be available in hospitals and only be used by medical personnel.

In fact, according to the risk level, medical devices are divided into three categories.

Class I medical devices has low risk level. The public can ensure the safety of use through learning and consulting the instructions. Many products can be used at home.

Some class II medical devices can be used for household.

Class III medical devices have high risk level. A few can be used for household under the instructions.

Misunderstanding 2

Some other devices are regarded as medical devices, such as some fitness, slimming, heightening and health care products. These devices have no medical device registration number, which can be clearly distinguished from this point.

Misunderstanding 3

Medical devices are more conducive to health than other devices.

Medical devices are special products. Their production and sales are subject to strict approval management. They have particular functions. The medical device should not be used for unsuitable people.

Other devices have a wider range of applications. Their main functions are not for medical purposes, but the respective functions of products.

As a manufacturer of medical devices, Perlove Medical currently have medical devices lines including DR lines, C-arm lines, DRF lines, and etc. We can supply products for different testing and procurement needs. If you are interested in our products, please leave us a message on our website.


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