CDSCO classifies 80 IVD medical devices under new medical device rules for their effective regulation

Compliance to New Medical Device Rules 2017

These 80 classified devices are covered under categories of clinical chemistry, hematology category, immunology and microbiology among others for effective regulation and patient safety. The Central Drugs Standard Control Organisation (CDSCO) has classified around 80 in-vitro diagnostic (IVD) medical devices under Medical Device Rules (MDR) -2017 based on risk based classification for their effective regulation. … Read more