Medical devices to be treated as drugs

Medical devices to be treated as drugs

1. The Health Ministry has announced certain medical devices viz.

a) all implantable devices,

b) CT scan,

c) PET and MRI equipment,

d) defibrillators,

e) dialysis machines and

f) bone marrow separators to be brought under the purview of Drugs and Cosmetics Act and thus treated as “drugs” with effect from 1^st April 2020.

2. Currently, only 23 medical devices are regulated under the Drugs and Cosmetics Act, 1940

3. Given that quality and efficacy of majority medical devices remains unregulated in India, the recent announcement is significant for patient’s safety as with this notification, all implantable and diagnostic devices will come under the regulatory framework.