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Expansion of Testing of IVD for Clinical chemistry at NIB

The National Institute of Biologicals(NIB), Noida is an autonomous body under the Ministry of Health and Welfare, GOI. The function of NIB is to assist CDSCO and other similar government bodies dealing with topics in the purview of the health sector of India.

As mentioned in a recent notification, following a change in the Medical Device Rules, 2014. NIB has now been assigned extra responsibilities with the testing of IVD devices for clinical chemistry reagent kits.

This expansion of testing has been made under the provisions of the sub-rule(2) rule 4 of the Medical Device Rules, 2017. These rules also specify the guideline for medical device registration in India.

Earlier the NIB was assigned with the responsibility of testing of five in-vitro diagnostic devices which included:
     Diagnostic kits for human immunodeficiency virus
     Hepatitis B surface antigen
     Hepatitis C virus
     Blood grouping reagents
     Glucose test strips fully automated analyser based glucose reagents

Under the new Medical Device Rules, 2017(w.e.f 1st January 2018), 247 IVD’s under the provisions of the sub-rule(2), rule 4 of these rules were added to this list.

Furthermore, in a latest notification, 42 newly notified clinical chemistry reagent kits have also been added to this list. The NIB will be responsible for the quality control testing of some of these newly notified products

What are Clinical Chemistry Reagent Kits

These kits comprise of reagents that are used in the testing of samples to obtain results in the form of a medical report. These reagent kits are the backbone of medical laboratories. Moreover, these reagent kits also fall under the purview of the medical equipment registration as per the rules.

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