MEDICAL DEVICE

These are devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.

In Vitro Diagnostic Devices (IVD)

In vitro diagnostic devices are devices used for diagnosis of diseases or any complications in humans or animals. As per the Drug and cosmetic act 1940, an IVD is considered as a drug. Hence all the regulations applicable for new drug approval are also subjected to new IVD.