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

If you plan to manufacture or import advanced medical devices in India, you must have the MD-15 license. This license is required for Class C and Class D devices, which are higher-risk products. Without it, selling or distributing these medical devices in India is not allowed.

This blog explains the MD-15 license in easy and simple language. You will learn what the license is, why it is important, and the steps to get it. Even if you are new to medical device regulations, this guide will help you understand the process clearly and confidently.

What is an MD-15 License?

The MD-15 license is an official approval from the CDSCO that allows you to import high-risk medical devices (Class C and Class D) into India. This license ensures that imported devices meet India’s safety and quality standards before they reach hospitals and patients.

In simple terms:

• Your device is high-risk
• You are importing it from another country
• You cannot sell or distribute it without MD-15 approval

Why it matters:

• Ensures safety and quality of medical devices in India
• Makes your imports legal and compliant with the law
• Builds trust with hospitals, clinics, and patients

The MD-15 license is issued under the Medical Devices Rules, 2017, and requires submission of technical documents, manufacturer details, and compliance reports. Following the rules carefully helps you get approval smoothly and avoid legal issues.

What is CDSCO?

CDSCO stands for Central Drugs Standard Control Organisation. It works under the Ministry of Health & Family Welfare, Government of India. CDSCO is the main authority that regulates drugs and medical devices in India to ensure they are safe and effective for use.

Key roles of CDSCO:

➜ Control drugs and medical devices to meet quality and safety standards

➜ Approve licenses for manufacturing, importing, and selling medical products

➜ Ensure patient safety by monitoring adverse effects and compliance

➜ Regulate imports and manufacturing to maintain legal and quality standards

In simple words, CDSCO is the authority that makes sure all medicines and medical devices in India are safe, reliable, and legally compliant before they reach patients.

What are Class C and Class D Medical Devices?

and examples of Class C & D devices:

Key Point:
Class C and D devices are strictly regulated because they directly impact human life, which is why importing or selling them in India requires the MD-15 license issued by CDSCO.

Examples of Class C & D Medical Devices

Class C and D devices are high-risk medical devices that can directly affect human life. Because of this, the government regulates them very strictly to ensure safety and quality.

Who Needs an MD-15 License?

If you want to import high-risk medical devices (Class C or Class D) into India, you must have an MD-15 license. This license ensures that the devices meet safety, quality, and regulatory standards before they can be sold or distributed in India.

You need an MD-15 license if:

➤ You are importing 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 (AIR) for a foreign manufacturer

Key Point: Without an MD-15 license, importing or selling these high-risk devices is illegal, and non-compliance can lead to fines, seizure of products, or other legal actions.

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

Getting an MD-15 license may seem complex, but following the steps carefully makes it smooth. This license is essential for importing Class C and Class D medical devices into India.

Step 1: CDSCO Login & Registration

• The importer or Authorized Indian Agent (AIR) creates an account on the CDSCO online portal.
• This account is used for all submissions and tracking the application.

Step 2: Prepare Documents

• Collect all technical, manufacturing, and legal documents related to the medical device.
• Double-check them to ensure they are complete and accurate before submission.

Step 3: Online Application Submission

• Fill out Form MD-14 on the CDSCO portal.
• Upload all the required documents along with the application.

Step 4: Fee Payment

• Pay the government fees online through the portal.
• Keep the payment receipt safe for future reference.

Step 5: CDSCO Review

• CDSCO officers review the application and documents.
• They may ask for additional clarification or documents if needed.
  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 or email us at : support@psrcompliance.com
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.