India’s regulatory framework for software as a medical device (SaMD)
£45.00
Enter India’s SaMD market: understand the regulatory framework, approval process, and compliance essentials for software as a medical device
English
India’s regulatory landscape for software as a medical device (SaMD) is rapidly evolving in response to the healthcare sector’s growing reliance on digital innovations such as artificial intelligence, wearables, and telehealth. Under the Medical Devices Rules, 2017, the Central Drugs Standard Control Organization has established a comprehensive framework to govern SaMD throughout the total product lifecycle – from design and development to post-market surveillance. This includes risk classifications, stringent quality management requirements, clinical investigations for higher-risk devices, and a detailed registration process. With recent mandates for version tracking, mandatory labelling, and continuous monitoring, both domestic and international stakeholders must navigate a dynamic, compliance-driven environment. This article by Sundeep Agarwal offers an in-depth look into India’s regulatory framework for SaMD, serving as a critical guide for developers, manufacturers, and importers aiming to bring their digital health solutions to the Indian market successfully.
Specification: 7 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the August 2025 issue of the Journal of Medical Device Regulation.
