In a bid to regulate medical and diagnostic devices in India, the health ministry has notified eight medical equipment, including all implantable devices, as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020.
The medical equipment include all implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator.
According to a notification,’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, defibrillators, dialysis machine, PET equipment, xray machine and bone marrow cell separator’
A majority of medical devices are unregulated in India. This move is important for patient’s safety as with this notification, all implantable and diagnostic devices will come under the regulatory framework.