18 Dec 2018
INDIA: Additional Medical Devices Set to Fall Within Drug Regulation Regime
As of 1 January 2020, nebulisers, glucometers, digital thermometers and blood pressure monitors are to be added to a list of some 23 medical devices have previously been re-classified as drugs by the Ministry of Health. As a consequence, the import, production and sale of these re-designated devices will automatically fall within the government’s drug quality and price regulation regime.
Although no exact timetable has been announced, the number of re-designated medical devices is expected to be expanded to include implantable items, CT scanners, MRI machines, defibrillators, dialysis machines, X-ray machines, PET equipment and bone marrow cell separators at a later date.