Is in vitro diagnostic instruments not needed to be registered in India ?

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Could anyone help us explain the following questions:

In vitro diagnostic instruments are not needed to register in India, right? The import license is only for In vitro diagnostic regents, right? For example, we have the products of Urine Test Strips and Urine Analyzer. The Urine Test Strips could be read by both of visually and urine analyzer. But the import license is only for Urine Test Strips.

Which regulation in India shows this request?

Thanks in advance!
 
Ajit Basrur

Ajit Basrur

Leader
Admin
Refer to this FAQ document from CDSCO - HERE

Refer to Question 62 on page 14 of 18 that states Blood Glucose strips are regulated while the Glucometer is not. I am not sure if the same logic can be held for urine analyzers.

Q 62. Whether Glucometers used for blood glucose monitoring are regulated under Drugs and Cosmetics Act and Rules?

Ans: As per current provisions of Drugs and Cosmetics Act and Rules Glucometers used for blood glucose monitor (instrument) are not regulated. However, test strips and reagents are regulated under Drugs and Cosmetics Act and Rules.

It is advised to get in touch with CDSCO.
 
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