Import Permissions for Research & Special Use
Import licences for clinical investigations, government-hospital investigational use, and personal-use small-quantity imports. Quantity-limited and purpose-specific — not for commercial distribution. Common pathways for early-access devices, investigator-initiated studies, and personal medical needs not yet served by Indian market approvals. Each route has distinct documentation rules, justification thresholds, and post-import reporting obligations.
6 CDSCO forms in this category
Application for Licence to Import Medical Devices for Clinical Investigations, Testing, Evaluation, Demonstration, or Training
Application for import license for medical devices intended for clinical investigations, testing, or training.
Licence to Import Medical Devices for Clinical Investigations, Testing, Evaluation, Demonstration, or Training
License granted to import medical devices for clinical investigations, testing, or demonstrations.
Application for Licence to Import Investigational Medical Devices for Government Hospitals or Statutory Medical Institutions for Treatment
Application for license to import investigational medical devices for government hospitals or statutory medical institutions.
Licence to Import Investigational Medical Devices for Government Hospitals or Statutory Medical Institutions
License granted for importing investigational medical devices for treatment in government hospitals.
Application for Permission to Import Small Quantities of Medical Devices for Personal Use
Application for permission to import small quantities of medical devices for personal use.
Permission to Import Small Quantities of Medical Devices for Personal Use
Permission granted to import small quantities of medical devices for personal use.
When you need these licences
Use this list to confirm whether this category applies to your device, role, or use case.
Research / investigation imports
For sponsors and CROs running Indian clinical investigations with foreign-manufactured devices.
Government hospital imports
For statutory medical institutions importing investigational devices for patient treatment.
Personal use imports
For individuals importing small quantities of devices for their own medical use (with prescription).
Documentation checklist
- Clinical investigation protocol (for MD-16/MD-17)
- Government hospital authorisation (for MD-18/MD-19)
- Medical prescription and condition description (for MD-20/MD-21)
- Foreign manufacturer credentials
- Quantity justification
- Intended use documentation
Step by step
- 01
Use case confirmation
Confirm pathway: clinical/research, government, or personal use.
- 02
Application preparation
Different document sets per pathway — research-heavy or institutional or personal-medical.
- 03
Filing via SUGAM
Application submitted with supporting evidence.
- 04
Review
Focused on use legitimacy and quantity reasonableness.
- 05
Permission grant
Limited-scope permission specifying quantities and use boundaries.
- 06
Customs clearance
Permission enables import through customs for specified purpose.
Common questions
MD-16 (application) and MD-17 (licence) cover devices imported for clinical investigations across multiple sites.
MD-18/19 are specifically for government hospitals or statutory medical institutions importing investigational devices for direct treatment — not standard clinical trials.
Yes — MD-20 applications must be supported by an Indian medical prescription explaining the medical necessity.
No. Personal-use imports are strictly for the named individual's medical use. Commercial distribution requires MD-15.
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