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