The MD-14 → MD-15 route
MD-14 filed on SUGAM leads to the MD-15 license — perpetual validity, 6–9 month typical timelines.
Free field guide · PDF
India CDSCO Medical Device Registration2026 Field Guide
The MD-14/MD-15 import route, the mandatory Indian Authorized Agent, and fees by class — for a 1.4-billion-patient market.
- MD-14 timeline
- 6–9 mo
- Perpetual license
- MD-15
- Fees per site
- $1K–3K
Sourced from CDSCO import-license guidance and MDR 2017 practice.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — CDSCO import-license guidance and MDR 2017 practice.
The Indian Authorized Agent
Foreign manufacturers cannot file directly — the agent files, answers queries, and handles vigilance.
Fees and the playbook
$1K–$3K per site plus per-device fees by class, clinical data for Class C/D, and why form consistency decides everything.
Sources & scope
- medicaldeviceregistration.in, MD-14 License India complete 2026 guide.
- medicaldeviceregistration.com, CDSCO MD-14/MD-15 import license guide 2026.
- legalraasta.com, medical device registration in India — CDSCO license.
- medicaldeviceregistration.in, CDSCO import license full process 2026.
This guide is market-access intelligence, not regulatory or legal advice. CDSCO pathways and fee schedules are product-specific — professional review is required before business use.
Market Access Strategy Session
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A Market Access Strategy Session maps your CDSCO route — classification, agent selection, and the MD-14 filing plan.
Professional review is required before business use.
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