Medical Device Regulatory Services India
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Regulatory Solutions India
Regulatory frameworks maybe complex but finding a Regulatory Partner should not be...
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Why RSI?

When it comes to choosing a regulatory partner, clients like you need somebody who has a strong understanding of the country's regulatory framework, a variety of products experience and a sense of urgency to deliver. We let our numbers speak to reflect these strengths of ours:

450+ Products  Registered

Since 2011, Over 450 products successfully registered across Medical Devices, IVD and Cosmetics in a background of an evolving Indian regulatory landscape

Across 20+ categories

Products registered across 20+ categories viz Stents, Catheters, Intraocular lenses, Orthopedic Implants, Ablation devices, Surgical dressings, Hypodermic Syringe / Needle and many more.

100% repeat business

Served clients from 15+ countries with a 100% repeat business.

Our Unique Strength

Our rich experience ensures that RSI offers a unique blend of technical, strategic and project management support in all assignments.

Regulatory Support for Medical Devices introduction into India

Import / Mfg. Licence

Dossier preparation

Query Response Drafting

Portfolio Analysis / Strategy

Voluntary Registration

Post Approval Change