Under the 2017 Medical Device Rules, it is legally required to undertake medical device testing in India under regulatory supervision in order to uphold safety and performance criteria.

What is a CDSCO Test License for Medical Devices?

Organizations manufacturing or importing medical devices into India are granted test permits by the Central Drugs Standard Control Organization (CDSCO) just for testing, evaluation, clinical research, or demonstration purposes—not for sale.

The Medical Device Rules, 2017 demand that medical device testing in India be conducted under regulatory supervision in order to uphold safety and performance standards.

Who Needs a Test License?

A CDSCO test license is required if you are:

  • A manufacturer intending to produce devices for R&D or clinical trials
  • An importer bringing in devices for demonstration or testing
  • A research organization conducting lab-based or field evaluations
  • A startup or medical tech innovator validating new device concepts

Medical Device Testing in India: Required License Types

There are two types of test licenses depending on your role:

1. Form MD-16 – For Import of Medical Devices for Testing

  • For importing medical devices not yet registered in India
  • Used for clinical investigation, R&D, and performance testing

2. Form MD-17 – For Manufacturing of Medical Devices for Testing

  • For domestic manufacturers producing test samples
  • Applicable for both regulated (Class A/B/C/D) devices

Documents Needed in India for a Medical Device License

To obtain a medical device license in India for testing, you'll need to submit:

  • Cover letter with purpose of license
  • Form MD-16 or MD-17 (whichever applicable)
  • Device Master File or Product details
  • Free Sale Certificate (for imports)
  • ISO 13485 certificate
  • Undertaking that the devices will not be sold
  • Details of clinical investigation plan or test protocol
  • Manufacturing license (for MD-17 applicants)
  • Import license (if applicable)

CDSCO Test License Application Process

Step 1: Register on the SUGAM Portal

Register under the relevant manufacturer/importer category by going to cdscoonline.gov.in.

Step 2: Fill in MD-16 or MD-17 Application Form

Select the license type and complete the form with device, organization, and purpose details.

Step 3: Upload Supporting Documents

Attach technical documents, safety certifications, test protocols, and more as per guidelines.

 Step 4: Pay Government Fees

  • Test License for Import (MD-16): ₹1,000 per device
  • Test License for Manufacturing (MD-17): ₹500 per device

 Step 5: Await CDSCO Review & Grant

In addition to document verification, the CDSCO may ask for explanations. The license is issued electronically upon approval.

Timeline for Approval

  • Preparation & Application: 5–7 days
  • CDSCO Review & Approval: 2–4 weeks

Note: There may be delays if inquiries are made if documentation is incomplete.

Final Thought

Getting a CDSCO Test License for Medical Devices is a crucial step in India's regulated medical innovation ecosystem. It ensures that all medical device testing conducted in India conforms with global quality standards and is conducted in accordance with the relevant safety and ethical guidelines.

Whether you're preparing for a large-scale clinical evaluation or proving a groundbreaking discovery, following India's medical device testing regulations not only avoids legal problems but also builds confidence among authorities and end users.

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