MD-13 Medical Device Test License
The MD-13 Medical Device Test License is a license granted under the Medical Devices Rules, 2017 by the Central Drugs Standard Control Organization (CDSCO). It allows manufacturers or importers to manufacture or import medical devices specifically for testing, evaluation, demonstration, or clinical investigation purposes, but not for commercial sale.
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Benefits
Legal Authorization for Testing
Enables companies to legally test or evaluate medical devices before launch.Essential for Clinical Trials & Validation
Required to perform clinical investigations, bio-compatibility, or usability testing.Faster Market Entry
Accelerates the development and approval process of new devices.Supports Innovation
Ideal for R&D, startups, and global companies entering the Indian medical device market.Improves Product Credibility
Demonstrates commitment to regulatory compliance and scientific validation.
Process
Consultation & Classification
Identify the device class and purpose of testing (clinical, demo, or analytical).Document Compilation
SRV Taxcon assists in preparing technical, administrative, and protocol documents.Application Submission
Submit Form MD-12 with prescribed fee via CDSCO’s SUGAM portal.CDSCO Review
Authorities assess the application. Any queries are promptly handled by our team.Grant of License in Form MD-13
Upon approval, CDSCO issues the MD-13 License authorizing testing activities.
Documents Required
Duly filled Form MD-12 application
Purpose of testing or investigation
Device description and specifications
Test protocol or clinical trial protocol (if applicable)
Ethics Committee approval (for clinical trials)
Undertaking regarding non-commercial use
Details of testing site/lab or institution
CE/FDA/ISO certificates (if applicable)
Manufacturer’s Authorization Letter (for importers)
What You’ll Get
Experts in CDSCO Licensing & SUGAM Portal
Specialized Support for Clinical & Non-Clinical Testing
Transparent Process & Timely Delivery
Compliance with India’s Medical Device Regulations
End-to-End Documentation & Regulatory Handling
Frequently Asked Questions
It is used for importing or manufacturing medical devices for testing, evaluation, or clinical investigation—not for commercial sale.
Manufacturers, importers, CROs, or institutions intending to test or clinically trial a device.
The license is valid for 3 years or as specified, depending on the purpose of testing.
No. Devices imported or manufactured under this license cannot be sold.
Yes. We assist with protocol preparation, ethics approvals, and CDSCO compliance.
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