What are medical devices?

2020-07-25

According to the current "Medical Device Supervision and Administration Regulations", medical devices refer to instruments, equipment, apparatus, in-vitro diagnostic reagents and calibrators, materials, and other similar or related articles used directly or indirectly on the human body, including the necessary computer software.

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What are the main forms of deceptive and misleading advertisements for in-vitro diagnostic reagents?

2019-05-22

(1) False advertising: The advertised products, services, or functions do not exist, with the purpose of defrauding customers of their money.

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Is it necessary for in-vitro diagnostic reagent products to be accompanied by labels and instructions for use?

2019-05-22

All in vitro diagnostic reagents sold and used within China must be accompanied by instructions for use and labels. The text content of medical device instructions for use and labels should use Chinese, and the use of Chinese should comply with national common language and writing standards.

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