CDSCO Approval for Imported Medical Devices: Process

CDSCO Approval for Imported Medical Devices: End-to-End Process

Obtaining CDSCO approval for imported medical devices in India requires strict adherence to the Medical Devices Rules, 2017. Importers and authorised Indian agents must determine the correct risk-based classification (Class A to D) and submit Form MD-14 through the official online portal to secure an MD-15 import licence. The document-heavy process requires key technical files, including a Power of Attorney, Device Master File, Plant Master File, and Free Sale Certificate. Understanding classification, fee structures, timelines, and post-approval labelling compliance ensures a seamless regulatory journey and prevents operational delays.

2026-09-2164Anshika Jindal

CDSCO Approval for Imported Medical Devices: End-to-End Process

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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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