GRIP

India

Health tech

A wellness app, a hospital workflow tool, and a medical device are three regulatory objects.

Startup EcosystemsIndiaHealth tech

Rules

The Central Drugs Standard Control Organization regulates drugs and, under the Medical Devices Rules of 2017, medical devices. A product that diagnoses, or that the law treats as a device, does not get to call itself software and skip that file. A scheduling or records product sold to a hospital may never be a device and still has to live with how hospitals buy and pay.

Clinical practice is a separate licence from device approval. Telemedicine has its own professional guidance. This page does not summarise it into permission. If the product touches a patient, the company’s lawyer reads the current text. GRIP will not guess the class of a device.

Who pays

Hyderabad’s life-sciences base is the closest Indian city cluster to laboratory and contract research. Chennai has a long private-hospital sector and the research park beside IIT Madras. Neither fact makes a national health-software market. Public hospitals, insurers, and private chains buy differently, and several of them pay slowly.

Export of a device or of a clinical service meets the importing country’s regulator as well as CDSCO. A domestic pilot in one hospital group is not that export.

Other sectors

Continue with GRIP

Cities and sectors are different maps.

A sector note says which rule and which customer. A city note says who can be hired. Neither is a ranking.