Eight New Medical Devices Brought under the Regulatory Purview of ‘Drugs’

The Ministry of Health and Family Welfare in consultation with the Drugs Technical Advisory Board has, by way of a notification dated February 8, 2019, introduced eight new medical devices under the purview of ‘drugs’, as defined under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 (‘DCA’). These devices include all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PET equipment, X-ray machine and bone marrow cell separator (collectively, ‘Medical Devices’), and are in addition to the pre-existing list of 23 other medical devices defined as ‘drugs’ under the DCA. The Medical Devices will be brought under the regulatory purview of the DCA and the Medical Devices Rules, 2017, with effect from April 01, 2020.

Published In:Inter Alia - Quarterly Edition - March 2019 [ English Chinese japanese ]
Date: March 31, 2019