AI-Driven Medical Devices and Software in the Spotlight as India Redefines Regulations

From the interpretation of big data for marketing activities and optimisation of land distribution and crops in agriculture to the optimisation of medical devices and treatments: new applications of technologies such as artificial intelligence (AI) have transcended the boundaries between sectors. However, keeping up with the pace of technological development on the regulatory level poses significant challenges, particularly in the medical industry. 

Since 2018, India has incorporated within the Medical Device Rules software solutions directly interacting with medical devices to treat or diagnose a wide range of diseases. Before this, such software was not subject to regulation, causing several legal uncertainties for their commercialisation and implementation.

However, the definition of software and the boundaries of what would constitute a medical application is constantly mutating given software’s new applications and forms, such as AI, as well as new, parallel uses, for example, tracking and programming a healthy habit in diet, sports, or mobility.

Aiming to compete with other western regions of the world, which also struggle to adapt their policies to these rapidly growing innovations, India is redefining some of the necessary regulations to be in the driving seat of this technological era.