What is Test License (MD-17)?
A Test License in Form MD-17 is an approval issued under the Medical Devices Rules, 2017 that allows importers or authorized agents to import IVD devices into India strictly for testing, evaluation, demonstration, or clinical performance studies.
This license is essential when your product is not yet approved for commercial sale but needs to be assessed in real-world or laboratory conditions. It ensures that imports are controlled, traceable, and used only for intended non-commercial purposes.
Without MD-17, importing unapproved IVDs even for internal validation can lead to regulatory violations.
When Do You Need MD-17 Support?
Support for importing IVD devices into India for testing, evaluation, demonstration, training, or clinical investigation purposes.
-
You should apply for an MD-17 license if you want to import IVD devices for laboratory testing or evaluation.
-
You are conducting performance evaluation or validation studies in India.
-
You need samples for demonstration to healthcare professionals.
-
You are preparing for product registration and need local data.
-
The IVD is not yet approved or registered in India.
-
Unclear definition of testing purpose vs. commercial intent.
-
Incomplete or inconsistent documentation.
-
Lack of clarity on quantity justification.
-
Regulatory scrutiny on safety and usage controls.
-
Coordination with CDSCO for approvals.
-
Managing timelines for urgent testing needs.
-
Handling queries.
Our Approach and What You Will Get
End-to-end support for regulatory assessment, application filing, query responses, and post-approval compliance for test license activities.
-
Regulatory assessment and testing strategy
-
Documentation preparation
-
Complete application filing
-
Query response handling
-
Post-approval compliance guidance.
-
Regulatory pathway assessment
-
MD-16 application preparation & filing
-
Cover letter and justification documentation
-
Test protocol and intended use documentation
-
End-to-end submission support
-
Query response handling
-
Post-approval compliance guidance
Why Choose Tacit Medtek and Case Example
Strong support for CDSCO import regulations, IVD evaluation, and performance study documentation to help achieve smoother approvals.
-
Strong experience with CDSCO import regulations
-
Thorough understanding of IVD evaluation and testing procedures
-
Focused documentation that minimizes queries
-
Faster turnaround through structured execution
-
Tailored support based on your testing objectives
-
Challenge: A diagnostics company planned to import a new IVD assay kit for performance evaluation but faced rejection due to insufficient justification of quantity and testing protocol.
-
Our Approach: We refined their documentation, clearly defined the testing plan, aligned the quantity with study requirements, and resubmitted the application.
-
Outcome: The client received MD-17 approval smoothly and completed their evaluation study within planned timelines.
FAQ
Frequently Asked Questions
MD-16 is the application form, while MD-17 is the test licence issued by CDSCO.
No, the license is strictly for testing, evaluation, or demonstration—not for commercial sale.
The Central Licensing Authority (CDSCO) issues the MD-17 licence.
Yes, the quantity must be justified based on your testing purpose.
Yes, Ethics Committee approval is required if the imported IVDs are used for clinical performance evaluation involving human participants or samples.
Enquire Now
Fill in the form and our team will get back to you shortly.
Reach our regulatory experts directly.