AI Medical Device Registration in India: CDSCO Guide 2026

How to Register AI-Driven Medical Devices with CDSCO?

This guide details CDSCO’s registration process for AI-driven medical devices under India’s Medical Device Rules, 2017. It explains how to classify software based on risk (Class A–D), prepare key technical documents like Device Master Files and algorithm data, and navigate manufacturing or import licensing

2026-09-1166Anshika Jindal

How to Register AI-Driven Medical Devices with CDSCO?

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About the Author

Anshika Jindal

Content Writer

Anshika Jindal, a Legal Content Writer with strong expertise in legal research and a solid academic background in BA LLB and LLM (Criminal Law). I specialize in researching statutes, case laws, and legal developments and presenting them in clear, accurate, and engaging written content. With strong analytical skills and attention to detail, I create reliable, well-structured legal content while maintaining professional and ethical standards.

I specialize in conducting in-depth legal research using credible sources and presenting legal information in a structured, reader-friendly manner while maintaining precision and authenticity. My work focuses on simplifying legal language without compromising its meaning, making legal content accessible to a wider audience.

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