India is one of the developing countries emphasizing on betterment of quality of life, quality of living, and quality of infrastructure through establishment of distinct regulatory guidelines. Considering the importance of manufacturing of high quality, safety, and performance of medical devices in mind, an act, Drugs and Cosmetics Act, 1940 has been introduced. 

This act is responsible for regulation of quality, performance, and safety of the medical devices (medical devices CDSCO). Moreover, to regulate the import, manufacture, clinical investigation, sale and distribution of medical devices, Medical Devices Rules, 2017 vide G.S.R. 78 (E) has been notified by the Drugs Technical Advisory Board.

Therefore, any medical device intended to be used for any medical purposes, typically used to diagnose and treat a patient to prevail over illnesses and disease, including improving the quality of life need to be certified. 

As important as it is to improve the quality of life, there are certain clusters of medical devices in India, (that is Maharashtra, Gujrat, Haryana, Karnataka, Tamil Nadu, and Andhra Pradesh, Telangana) which are hub for manufacturing of medical devices. Though, considering the importance of manufacturing of medical devices, the Government of India has set a target to establish at least 25 medical device manufacturing units in each state by the year 2025.

Let’s understand the market scenario of Indian medical devices.