From April 1, CDSCO to monitor medical devices
According to the latest notification by the Ministry of Health and Family Welfare, from 1st April’20, all medical devices, including implants and contraceptives, will be brought under the lens of the Central Drugs and Standard Control Organization (CDSCO). Earlier, private notified bodies inspected low-risk (i.e. Class A and B) devices, while CDSCO issued licenses. For high-risk (i.e. Class C and D) devices, CDSCO was responsible for both inspection and licensing. Some of the examples of the former category include surgical dressing, alcohol swabs, thermometers, blood pressure monitoring devices among others; while implants, hemodialysis catheters, angiographic guide wire and heart valve come under the latter category. It is being said by the sources that these categories will be revised.
“That structure will remain, but this notification will make enforcement of norms for medical devices more stringent and bring them on a par with drugs, a senior government official stated. This scrutiny comes in the aftermath of Johnson & Johnson’s faulty hip implants.