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Regulating Software as Medical Devices – Navigating Hurdles One Byte at a Time

Transitioning Regulatory Landscape

Dynamic progress in healthtech and medtech has led to a transformative surge of the medical devices landscape, propelling the rise of new and innovative medical devices. However,  preceding the amendments to the Medical Devices Rules, 2017 (“MD Rules”), only a handful of medical devices were regulated, with software escaping regulatory scrutiny. Recognising the myriad instruments affecting individual and animal health, the Government found it imperative to extend regulations to this rapidly evolving realm. Continue Reading Regulating Software as Medical Devices – Navigating Hurdles One Byte at a Time

The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation

In an earlier blog post, we took a close look at the National Medical Devices Policy, 2023 (“Policy”), notified by the Department of Pharmaceuticals (“DoP”) on May 2, 2023[1]. We delved into the framework, objectives and core focus areas of the Policy. While the aim of the Policy was clearly to reduce import dependency and establish India as a global manufacturing hub for medical devices, little information was provided on the means to achieve these goals. To draw a holistic picture, we sought guidance from the Approach Paper to the National Medical Devices Policy, 2022 (“Approach Paper”)[2], which was based on similar principles and furthered the same goals as the present Policy. However, the DoP has recently also issued a strategy document on the Policy (“Strategy Document”)[3] to fine-tune and expand on its implementation strategies. In light of the same, this blog post analyses the Strategy Document, measures envisaged thereunder, enforcement priorities and focal points.Continue Reading The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation