CDSCO releases Risk classification of newly notified Medical Devices, IVDs; Details

Through a recent notification, country’s central medical device regulator, the Central Drugs Standards Control Organization (CDSCO) has issued a risk classification of newly notified medical devices and IVDs on the basis of their intended use under the provisions of the Medical Devices Rules, 2017. Medical devices other than in vitro diagnostic medical devices will be classified on the basis of parameters specified in part I of the first schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D. In vitro diagnostic medical devices will be classified on the basis of parameters specified in part II of the First Schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D.

[Courtesy: https://business.medicaldialogues.in/cdsco-releases-risk-classification-of-newly-notified-medical-devices-ivds-details/