Following consultation with the Drugs Technical Advisory Board, the health ministry has newly notified eight medical devices, including all implantable devices, as "drugs" under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020. Henceforth these devices, along with the already-notified ones, will be closely regulated and monitored.
The medical devices include
- all implantable medical devices,
- CT scan,
- MRI equipment,
- dialysis machine,
- PET equipment,
- X-ray 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.
Gazette Notification S.O. 775(E)