Summary: The CDSCO’s Draft Guidance on Medical Device Software only clarifies how the existing Medical Devices Rules apply to software across its lifecycle, but does not create any new regulatory requirements. Its significance lies in signalling a more structured, risk-based and lifecycle-oriented approach to regulating software-driven healthcare products in India.Continue Reading Medical Device As Software: Has CDSCO Guidance Changed The Rules?
The medical devices sector in India is undergoing rapid transformation, driven by evolving regulations, technological advancements and growing healthcare demands. It is expected to grow to $20.51 billion by 2029. The demand for imported medical devices increased by 21% between November 2022 and October 2023, totalling medical device imports of INR 61,262.84 crore ($7.23 billion)[1]. The regulatory ambit governing medical devices in the country has seen significant reforms aimed at ensuring safety, quality and accessibility. For healthcare products, where precision and reliability are vital, stringent labelling regulations serve as a cornerstone for ensuring safety, quality, and consumer confidence. The regulatory framework for labelling of medical devices in India is governed by multiple legislative frameworks, each designed to uphold stringent standards.Continue Reading Double Check: Decoding India’s Dual Framework for Medical Device Labelling