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

Publication Time:

2019-05-22 15:29

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.

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

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. Other languages may be added to medical device instructions for use and labels, but the Chinese version should be considered authoritative.

The text, symbols, tables, numbers, and graphics in medical device instructions for use and labels should be accurate, clear, and standardized.

What is the meaning of the instructions for use and labels for in-vitro diagnostic reagents?

The instructions for use of in-vitro diagnostic reagents contain important information such as the intended use of the product, experimental methods, interpretation of experimental results, and precautions. It is an important technical document that guides users to operate correctly and helps clinicians understand and reasonably apply experimental results.

The label of an in-vitro diagnostic reagent product refers to the text descriptions, graphics, and symbols attached to the in-vitro diagnostic reagent or its packaging to identify product characteristics and indicate safety warnings.

How to understand the instructions for use of in-vitro diagnostic reagents?

The information contained in the instructions for use of in-vitro diagnostic reagent products has been reviewed during the product registration process. The results are data-supported, the operating procedures are validated, and the remaining risks of the product are clearly indicated. If the content in the instructions for use is a citation, the source of the reference should be indicated.

It should be noted that the same reagent may have slightly different descriptions in the instructions for use from different companies. This is mainly due to the differences in the product itself, as well as differences in intended use, research work, or operating procedures.

Attention should also be paid to the applicable models and accompanying reagents of the reagent. These are the basic elements that constitute the detection system and must be within the approved scope; otherwise, they do not belong to the approved product.


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