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.
Insights
Regulatory insights for regulated products
Guides, regulatory updates and sourced facts for nutraceuticals, medical devices, cosmetics and pharmaceuticals — written for the people who have to act on them.
Latest
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.
Regulatory update
ICH E6(R3) is now final: what it means for trials in India
The new good clinical practice guideline is final. Here is what changed, how it reaches trials run in India, and the steps to take now.
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.
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Nutraceuticals
Can I sell this as a supplement, and what am I allowed to say about it?
Medical Devices
What class is my device, and what evidence does that route require?
Cosmetics
What does it take to put this cosmetic on the Indian market?
Pharmaceuticals
How do I get this study approved and run in India?
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.