In an endeavour to regulate the quality of commonly used devices which play a crucial role in healthcare delivery, the Health Ministry has decided to bring eight new high-end medical devices including X-ray machines, MRI and CT scan equipment, and dialysis machines under the purview of Drugs and Cosmetics Act. The Union Ministry of Health and Family Welfare has notified these devices as ‘drugs’ with effect from April 1, 2020.
The list also includes defibrillators, PET equipment, and bone marrow cell separator. “In pursuant of sub-clause (IV) of clause (b) of section 3 of the Drugs and Cosmetics Act of 1940, the central government after consultation with the drugs technical advisory board hereby specifies The following devices intended for use in human beings as drugs with effect from the first day of April 2020 namely: All implantable medical devices CT scan equipment MRI equipment…
