The Drugs Controller General (India) has classified around 80 in-vitro diagnostic medical devices including analysers, instruments and softwares, under the Medical Devices Rules, 2017, based on the intended use, risk associated with the device and other parameters.

Around 53 IVD analysers were classified through the order, including 20 devices in the clinical chemistry category, around 13 in the hematology category, eight in immunology category, seven in microbiology and five in other category.

A total of 19 IVD instruments including blood smear instrument (Classification A), blood tube mixer (A), blood component separator (A), blood collection tube (A), cell washer (A), microbial incubator/imaging system (A), microplate seal roller (A), microscope slide maker/stainer (A), microscope slide washer (A) and specimen processing instrument (A), were listed under the classification.

Another eight classifications has been on IVD software, including cancer cell marker/morphology image-analysis software (Classification C), cancer risk assessment interpretive software (C), cardiovascular risk/probability assessment interpretive software (C), human genomic analysis interpretive software (C), laboratory instrument/analyser application software (A), osteoporosis risk assessment interpretive software (A), among others.

According to the rules, Class A is for low risk, Class B for low moderate risk, Class C for moderate high risk and Class D for high risk.

The notice says that the software, which drives a device or influences the use of a device, falls automatically in the same class. Software that is not incorporated in an in vitro diagnostic medical device, shall be classified using the classification provisions as specified in the relevant portion of Medical Devices Rules, 2017.