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
Medical Devices insights
What class is my device, and what evidence does that route require? Guides, updates and sourced facts for medical devices, alongside our medical devices sector page.
Medical Devices insights
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.