What is a CDSCO Test License?
A CDSCO Test License is a regulatory approval issued by the Central Drugs Standard Control Organization (CDSCO) that allows manufacturers or importers to manufacture or import limited quantities of medical devices for:
- Testing
- Evaluation
- Clinical Investigation
- Performance Verification
- Demonstration
- User Training
A Test License is intended for non-commercial purposes only and does not permit the commercial sale or distribution of medical devices in India.
Step-by-Step Process to Apply for a CDSCO Test License
CDSCO Test License for Manufacturing
- Step 1: Identify the Device and Purpose
Determine the medical device/IVD and whether it is required for testing, evaluation, examination, demonstration, training, or clinical investigation.
- Step 2: Prepare Required Documents
Prepare the device details, specifications, manufacturing details, quantity, test requirements, labels, and other applicable documents.
- Step 3: Submit Form MD-12
Submit the application for the test license through the applicable CDSCO online portal.
CDSCO reviews the application and supporting documents.
- Step 5: Respond to Queries
Provide clarification or additional documents if requested by CDSCO.
- Step 6: Obtain Form MD-13
After approval, CDSCO issues the Test License for Manufacturing in Form MD-13.
CDSCO Test License for Importing
- Step 1: Identify the Device and Purpose
Determine the device/IVD to be imported and its intended purpose.
- Step 2: Determine the Required Quantity
Specify and justify the quantity required for testing, evaluation, examination, demonstration, training, or clinical investigation.
- Step 3: Prepare Required Documents
Prepare device specifications, manufacturer details, labels, IFU, test requirements, and other applicable documents.
- Step 4: Submit Form MD-16
Submit the application for the import test license through the applicable CDSCO online portal.
CDSCO reviews the application and supporting documents.
- Step 6: Respond to Queries
Provide additional information or clarification if requested.
- Step 7: Obtain Form MD-17
After approval, CDSCO issues the Test License for Importing in Form MD-17.
Documents Required for a CDSCO Test License
Submitting a complete and accurate application is essential for obtaining a CDSCO Test License without unnecessary delays. The required documentation may vary depending on whether you are applying for a manufacturing or import test licence and the intended purpose of the device.
Our regulatory consultants help you prepare, review, and organize all required documentation before submission.
Common Documents Required
- Device description and intended use
- Product specifications
- Test protocol or clinical investigation plan
- Justification for the quantity of devices required
- ISO 13485 Certificate (if applicable)
- Quality Management System (QMS) documents
- Device label and Instructions for Use (IFU)
- Authorization Letter (for import applications)
- Supporting technical documentation
- Any additional documents requested by CDSCO
Before submission, every document is reviewed to reduce regulatory queries and improve application quality.
Checklist: CDSCO Online System for Medical Devices checklist portal
Why Choose Maven?
Choosing the right regulatory partner is essential for obtaining a CDSCO Test License efficiently.
With 10+ years of regulatory consulting experience, 350+ medical device and IVD manufacturers supported, and 500+ successful regulatory projects, Maven provides practical, end-to-end regulatory solutions tailored to your business needs.
FAQ:
A CDSCO Test License allows manufacturers or importers to manufacture or import limited quantities of medical devices for testing, evaluation, clinical investigation, demonstration, or training purposes.
Indian manufacturers, foreign manufacturers, importers, Authorized Indian Agents, IVD manufacturers, and research organizations may require a Test License before conducting testing or evaluation activities.
MD-12 is the application form used to obtain a manufacturing Test License for medical devices.
MD-13 is the Test License issued by CDSCO after approval of the MD-12 application.
MD-16 is the application form used for obtaining an Import Test License for medical devices.
MD-17 is the Test License issued by CDSCO after approval of the MD-16 application.
No. A Test License only permits testing, evaluation, clinical investigation, demonstration, or training. Commercial sale is not permitted.
