Test License for Medical Devices – Overview
Get your CDSCO Test License quickly and without delays. We help medical device manufacturers and importers obtain approval for testing, evaluation, and clinical investigations under the Medical Devices Rules, 2017.
- End-to-end documentation support
- SUGAM portal submission handled
- Faster approval with expert guidance
Read about CDSCO Classifications of Medical Devices
To commence medical device manufacturing, one must initiate the process by submitting an application for a Test License via Form MD-12 on the designated online portal of the Ministry of Health and Family Welfare.
Looking For a Medical Device Regulatory Consultant?
Let’s have a word about your next project
This license specifically authorizes activities related to testing, evaluation, demonstration, and training. Following the application, the Ministry will issue the Test License in Form MD-13.
Click here for CDSCO Manufacturing License for Medical Devices
What is a CDSCO Test License?
A CDSCO Test License is an approval issued under the Medical Devices Rules, 2017 that allows manufacturers or importers to produce or import limited quantities of medical devices for:
- Testing and evaluation
- Clinical investigation
- Demonstration or training purposes
Application Form: MD-12
License Issued: MD-13
This license is mandatory before conducting testing activities on regulated medical devices in India.
When Do You Need a CDSCO Test License?
You need a test license if you are planning to:
- Conduct clinical investigations in India
- Test product performance or safety
- Import devices for evaluation or validation
- Demonstrate products to distributors or hospitals
- Train users before commercial launch
👉 Not sure if your device requires a test license?
Talk to our regulatory expert
Types of CDSCO Test License
1. Test License for Manufacturing (MD-12 → MD-13)
Issued to Indian manufacturers to produce small quantities of devices for testing and evaluation.
2. Test License for Import (MD-16 → MD-17)
Issued to importers for bringing medical devices into India for testing, demonstration, or clinical investigation.
CDSCO Test License Process in India
We simplify the entire approval process for you:
Step 1: SUGAM Portal Registration
Create and verify your account on the CDSCO SUGAM portal.
Step 2: Application Preparation (MD-12 / MD-16)
Prepare and compile all required technical and regulatory documents.
Step 3: Documentation Submission
Upload application along with supporting documents.
Step 4: Government Fee Payment
Pay applicable CDSCO fees.
Step 5: CDSCO Review
Regulatory authority reviews your application and may raise queries.
Step 6: License Grant (MD-13 / MD-17)
Approval is issued upon successful review.
⏱ Typical Timeline: 4 to 8 weeks (depends on documentation quality and queries)
Get Expert Consultation Services for Medical Device Compliance
Documents Required for CDSCO Test License
To obtain a CDSCO test license, you need:
- Device description and intended use
- Test protocol or clinical investigation plan
- Justification for quantity required
- ISO 13485 certificate or QMS details
- Labeling and Instructions for Use (IFU)
- Authorization letter (for importers, if applicable)
Incomplete or incorrect documentation is the most common reason for delays.
Common Challenges in Getting CDSCO Test License
Many applicants face delays due to:
- Incorrect device classification
- Incomplete or non-compliant documentation
- Errors in SUGAM portal submission
- CDSCO queries and technical clarifications
- Poorly defined test protocols
👉 We help you avoid these issues and get faster approvals.
Why Choose Operon Strategist?
- Strong experience in CDSCO regulatory approvals
- Dedicated team for medical device compliance
- End-to-end support from documentation to approval
- Quick response to CDSCO queries
- Focus on faster turnaround and approval success
Frequently Asked Questions (FAQs)
MD-12 is the application form for a test license, and MD-13 is the license issued after approval.
It usually takes 4 to 8 weeks, depending on the accuracy of documentation and CDSCO review timelines.
No. A test license is strictly for testing, evaluation, or demonstration purposes only.
Yes, it is mandatory for conducting testing, clinical investigation, or demonstration of regulated medical devices in India.
The validity depends on the purpose and conditions defined by CDSCO.
