Test License for IVD Devices
(Forms MD-16, MD-17)
Legally import limited quantities of IVD medical devices for essential pre-market activities, including clinical investigations, evaluations, and training.
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What Are Forms MD-16 & MD-17?
Before commercial launch, manufacturers and importers often require limited quantities of an IVD device for non-commercial purposes. The CDSCO strictly regulates this through the "Test License" pathway, ensuring critical pre-market activities are conducted compliantly.
Form MD-16: Application
Submitted to the Central Licensing Authority, detailing the specific IVD, the exact quantity requested, and the precise non-commercial purpose (e.g., performance evaluation).
Form MD-17: License
The official Test License, typically valid for three years. Devices imported under MD-17 are strictly prohibited from commercial sale or distribution.
Strategic Value of the Test License
Enabling Essential R&D
Crucial for novel IVDs requiring clinical investigations and performance evaluations tailored to the Indian population.
Supporting Training & Demonstration
Permits the import of devices specifically to train healthcare professionals on proper use, facilitating successful market adoption.
Strategic Market Entry
Lays the compliant groundwork for full commercialization by enabling preliminary integration and testing within local systems.
The Application Process
Justification of Quantity
A rigorous rationale for the exact quantity requested, including a breakdown (e.g., test vs. retention).
Test Protocol Submission
For clinical investigations, an approved PEP or test protocol must be provided.
Non-Commercial Undertaking
A binding declaration stating devices will not be sold or distributed commercially.
CDSCO Sugam Registration
Complete online submission via the Sugam portal, including fee payment (USD 100 per distinct device).
Streamline Your MD-17 License
Obtaining a test license requires precise adherence to regulatory guidelines regarding quantity justifications and test protocols.
- Strategic justification of import quantities
- Meticulous MD-16 dossier preparation
- Sugam portal navigation & submission