Guide
Drug-device combination products: how India regulates them
A product that is part device and part medicine raises one question first: which rules apply? Here is how India answers it, and how the US and EU compare.
Insights
Guides
Plain-English explainers on how regulatory routes, classifications and clinical requirements actually work, written for the people who have to act on them.
Guides
Guide
Medical device classification in India: how it works
A plain guide to the four risk classes under the Medical Devices Rules, 2017, how to place your device in one, and what the class changes.
Guide
Wellness devices: when India treats them as medical devices
A step counter is not a medical device. A pulse oximeter is. Here is where India draws the line for wearables and apps, and what pushes a product over it.
Not sure which route applies to your product?
A Readiness Assessment confirms the regulatory route and the evidence it needs, before you commission testing against the wrong requirement.