MD-13 Medical Device Test License

Experience a seamless, hassle-free & timely registration with our expert consultants.

✔Our in-house team handles over 50 types of business licenses.
✔We provide end-to-end services across India.
✔Ensuring smooth and continuous adherence to all legal requirements.

Justdial

4.8

Google

4.8

Call Now »

Free Consultation by Expert

Benefits of MD-13 Test License

✔Legal Authorization for Testing and Evaluating Medical Devices
✔Essential for Clinical Trials and Bio-Compatibility Validation
✔Faster Market Entry by Accelerating Device Approval Process
✔Supports Innovation for R&D, Startups, and Global Companies
✔Improves Product Credibility with Regulatory Compliance

Applicability

MD-13 Test License is required for:

✔Companies conducting clinical investigations on medical devices
✔R&D organizations testing new device prototypes in India
✔Foreign manufacturers seeking device evaluation in Indian labs
✔Startups developing innovative medical devices
✔Institutions performing bio-compatibility or usability testing

Licensing Process

Consultation & Classification

Identify the device class and purpose of testing (clinical, demo, or analytical).

Document Compilation

Prepare technical, administrative, and protocol documents for submission.

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)

Client Testimonials

“Words from happy clients who chose us with confidence”

Google Customer Rating

4.8 ★★★★★

Justdial Customer Rating

4.8 ★★★★★

Rajesh Sharma

★★★★★

Founder, RS Enterprises

“Bizotic Supervision Private Limited made our GST registration process incredibly smooth. Their team handled everything from documentation to filing, saving us weeks of effort. Highly recommended for any startup!”

Priya Mehta

★★★★★

Director, Mehta Foods Pvt. Ltd.

“We needed FSSAI licensing urgently and Bizotic Supervision Private Limited delivered within the promised timeline. Their expertise in food business compliance is exceptional. Our go-to partner for all registrations.”

Amit Gupta

★★★★★

CEO, Gupta Trading Co.

“From company incorporation to annual ITR filing, Bizotic Supervision Private Limited has been our trusted partner for 3 years. Their pricing is transparent and service quality is consistently excellent.”