Jan 20, 2018
IVD Classification System: 2018
In India, In -Vitro Diagnostic kits/reagents are regulated under the provisions of the Medical Device Rules, 2017.
IVD’s are defined as substances intended to be used outside human or animal bodies for the diagnosis of any disease or disorder in human beings or animals covered under sub-clause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and IVDs that are notified, from…
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