I. WHAT IS A MEDICAL DEVICE?
The import, manufacture, sale, and distribution of medical
devices in India is regulated under the Drugs and Cosmetics Act,
1940 ("Act"), the Medical Devices Rules,
2017 ("Rules"), and the notifications
issued under the Act.
Under a notification issued by the Department of Health and
Family Welfare, software that is intended by its manufacturer to be
used specially for human beings or animals which does not achieve
the primary intended action in or on human body or animals by any
pharmacological, immunological, or metabolic means, but which may
assist in its intended function by such means for one or more of
the specific purposes of (i) diagnosis, prevention, monitoring,
treatment or alleviation of any disease or disorder; (ii)
diagnosis, monitoring, treatment, alleviation or assistance for,
any injury or disability; (iii) investigation, replacement or
modification or support of the anatomy or of a physiological
process; (iv)
