The MD-22 track
Form MD-22 application, MD-23/MD-25 permissions, the one-year start clock, CTRI registration, and annual CDSCO reporting.
Free field guide · PDF
India CDSCO: Clinical Investigation2026 Field Guide
The MD-22 track, the software rules, and the evidence bar — with the CDSCO practice you need.
- Application
- MD-22
- Start clock
- 1 yr
- Registration
- CTRI
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The software rules
CLA permission for IMD/new-IVD studies, the Algorithmic Change Protocol, and NSWS test licences.
The evidence bar
The CDSCO AI documentation bar, the CER evidence mix, and the country-of-origin approval precondition.
Sources & scope
- medicaldeviceregistration.com, Clinical Investigation (CDSCO forms & practice).
- pib.gov.in, SAHI and BODH Launched at India AI Impact Summit (10 Mar 2026).
- medianama.com, Draft Guidelines For Medical Device Software In India.
This guide is market-access intelligence, not regulatory or legal advice. CDSCO investigation requirements, form practice, and guidance drafts change — professional review is required before business use.
Market Access Strategy Session
India on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your CDSCO route — MD-22 positioning, software compliance, and evidence strategy.
Professional review is required before business use.
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