MD-15 License for Class C & Class D Medical Devices (2026)

If you are planning to manufacture or import advanced medical devices in India, you must understand the MD-15 license.
Without this license, selling or distributing Class C and Class D medical devices is not allowed in India.

This blog explains the MD-15 license in very simple words, so even someone new to medical device laws can understand it easily.

What is an MD-15 License?

The MD-15 license is an official approval given by the CDSCO for importing Class C and Class D medical devices into India.

In simple words:

• If your medical device is high risk
• And you are importing it from another country

Then you must get MD-15 approval

This license is issued under the Medical Devices Rules, 2017.

What is CDSCO?

CDSCO full form is
Central Drugs Standard Control Organisation

CDSCO works under the Ministry of Health & Family Welfare, Government of India.

Its job is to:

➜ Control drugs and medical devices

➜ Approve licenses

➜ Ensure patient safety

➜ Regulate imports and manufacturing

What are Class C and Class D Medical Devices?

Medical devices are divided into four risk categories:

● Class A – Low risk

● Class B – Low to moderate risk

● Class C – Moderate to high risk

● Class D – High risk (life-saving or life-support devices)

Examples of Class C & D Devices:

⁃ Ventilators

⁃ Dialysis machines

⁃ Cardiac stents

⁃ MRI and CT scan equipment

⁃ Implantable medical devices

⁃ Heart valves

Because these devices directly affect human life, government control is very strict.

Who Needs an MD-15 License?

You need an MD-15 license if:

➤ You are an importer of Class C or D medical devices

➤ The device is manufactured outside India

➤ You want to sell or distribute it in India

➤ You are acting as an Authorized Indian Agent

Why MD-15 License is Important

MD-15 license is important because:

➝ It ensures patient safety

➝ It allows legal import

➝ It builds trust with hospitals

➝ It avoids penalties and seizure

➝ It protects your business from legal trouble

Without this license:

• Products can be seized
• Imports can be stopped
• Heavy penalties may be imposed

Where Do You Apply for MD-15 License?

The application is done online using the CDSCO MD Online portal.

Commonly used terms:

▪ CDSCO login

▪ CDSCO online

▪ CDSCO MD online

▪ SUGAM portal (for medical device licensing)

Everything is now digital. No physical files are accepted.

Documents Required for MD-15 License

Here are the main documents, explained simply:

→ Import license application (Form MD-14)

→ Free Sale Certificate from country of origin

→ Device Master File (DMF)

→ Plant Master File (PMF)

→ ISO 13485 certificate

→ CE certificate (if available)

→ Authorization letter from manufacturer

→ Indian Agent details

→ Undertaking and declarations

→ Labeling details

→ Risk classification proof

These documents help CDSCO understand:

• How the device is made
• Whether it is safe
• Whether the manufacturer follows quality rules

Step-by-Step Process to Get MD-15 License

Step 1: CDSCO Login & Registration

First, the importer or Indian Agent creates an account on the CDSCO online portal.

Step 2: Prepare Documents

All technical and legal documents are collected and checked carefully.

Step 3: Online Application Submission

Form MD-14 is filled online and documents are uploaded.

Step 4: Fee Payment

Government fees are paid through the portal.

Step 5: CDSCO Review

CDSCO officers review the application.
They may:

• Ask questions
• Request clarification
• Ask for extra documents

Step 6: Approval & MD-15 License Issuance

Once satisfied, CDSCO issues the MD-15 import license.

How Long Does MD-15 Approval Take?

Normally:

45 to 90 days, depending on:

• Device complexity
• Document accuracy
• Query response time

High-risk devices may take slightly longer.

Validity of MD-15 License

The MD-15 license is valid for 5 years.

After expiry:

• Renewal must be applied before the due date
• Selling without renewal is illegal

Not sure whether you need an MD-15 license or how to apply?

Talk to our compliance expert and get clear guidance in simple language—no confusion, no pressure.

📞 Call PSR Compliance at 7065883416
We’ll help you understand the process and move forward the right way.

FAQs on MD-15 License for Class C & Class D Medical Devices

📌 What is an MD-15 License?

An MD-15 License allows import of Class C and D medical devices in India under CDSCO.

📌 Who needs an MD-15 License?

Foreign manufacturers need an Indian Authorized Agent to import Class C and D devices.

📌 What is the difference between Class C and Class D devices?

Class C devices are moderate risk, while Class D devices are high-risk or life-supporting.

📌 Can CE or FDA approval replace CDSCO approval?

No, CDSCO approval is mandatory for selling medical devices in India.

📌 Which form is used to apply for an MD-15 License?

Form MD-14 is used to apply, and MD-15 is issued after approval.

📌 What documents are required for an MD-15 License?

Key documents include QMS certificates, Device Master File, and authorization letters.

📌 What is a Neutral Code in MD-15 licensing?

A Neutral Code is an identification code for specific devices or applicants.

📌 How long does MD-15 approval take?

MD-15 approval usually takes 6 to 12 months, depending on documentation.

📌 What is a change of constitution under MD-15?

Changes in ownership or company structure require CDSCO approval.

📌 Is a new license required for minor device changes?

Yes, changes like sterilization methods may require fresh approval.

📌 What about devices already in the market?

Existing devices may qualify under CDSCO transition or grandfathering provisions.