Manufacturing for Clinical Trials
Licences to manufacture medical devices specifically for clinical investigations, testing, evaluation, demonstration, or training purposes. Restricted-purpose authorisations — devices produced under them cannot be commercialised. Required upstream of a clinical investigation permission (MD-22) and tied to the protocol approved by CDSCO. Typical use cases include investigator-initiated trials, pivotal studies, and engineering builds for design verification.
2 CDSCO forms in this category
Application for Licence to Manufacture Medical Devices for Clinical Investigations, Testing, Evaluation, Demonstration or Training
Application for a license to manufacture medical devices for clinical investigations, tests, or training purposes.
Licence to Manufacture Medical Devices for Clinical Investigations, Testing, Evaluation, Demonstrations, or Training
License granted for manufacturing medical devices for clinical investigations, testing, or demonstrations.
When you need these licences
Use this list to confirm whether this category applies to your device, role, or use case.
Investigational devices
Devices not yet commercially licensed but needed for clinical investigation or testing.
Clinical investigation plan
Approved or in-process clinical investigation requiring devices.
GMP-aligned facility
Manufacturing capability appropriate to the device complexity and risk class.
Documentation checklist
- Clinical investigation plan or testing protocol
- Intended use and study population
- Manufacturing site details
- Quality management documentation
- Risk management for investigational use
- Number of devices to be manufactured
- Distribution plan (investigator sites)
- Application fee
Step by step
- 01
Investigation scoping
Define use case: clinical trial, evaluation testing, training, or demonstration.
- 02
MD-12 filing
Application with protocol and quality documentation to CDSCO.
- 03
Technical review
Focused on safety for investigational use, not full commercial standards.
- 04
Inspection (if required)
For complex investigational devices, facility inspection may apply.
- 05
Licence issuance (MD-13)
Limited-purpose licence specifying quantity and use restrictions.
- 06
Conversion path
Successful investigation outcomes feed into commercial MD-5 / MD-9 applications.
Common questions
No. MD-13 licences are strictly for investigational, testing, evaluation, demonstration, or training use. Commercial sale requires MD-5, MD-9, or MD-15.
MD-13 covers manufacture of the device; MD-22/MD-23 cover conducting the clinical investigation itself. Both are typically needed in parallel.
Yes, via amendment with appropriate justification — typically straightforward if within original scope.
Typically 6–10 weeks. Faster for simple device types; longer for novel implantables or active devices.
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