CDSCO MD-14 vs MD-15: Complete Guide for Medical Device Import License in India

If you plan to import medical devices into India, you will encounter two important terms: MD 14 vs MD 15 CDSCO . However, many importers and foreign manufacturers feel confused about their roles.

So, what exactly is the difference? More importantly, which one do you need?

In this guide, we will clearly explain CDSCO MD 14 & MD 15, including their purpose, process, and how to avoid costly mistakes. Moreover, this article will help you take the next step toward obtaining your CDSCO import license smoothly.

Learn more about our complete Medical Device Import License India.

What is MD-14 in CDSCO?

MD-14 is the application form submitted to CDSCO for obtaining a medical device import license.

In simple terms, it is the first step in the licensing process. The importer or Indian Authorized Agent files this form through the CDSCO Sugam portal.

Key points:

• It is an application, not a license

• Submitted by importer or authorized agent

• Includes all technical and regulatory documents

What is MD-15 in CDSCO?

MD-15 is the official import license issued by CDSCO after approval of MD-14.

Therefore, once CDSCO reviews and approves your application, it grants MD-15, which allows you to legally import medical devices into India.

Key points:

• It is the final license

• Issued by CDSCO

• Mandatory for importing notified medical devices

MD 14 vs MD 15 CDSCO: Key Differences

Understanding MD 14 vs MD 15 CDSCO is essential for every importer.

In short, MD-14 starts the process, while MD-15 completes it.

When Do You Need MD 14 vs MD 15 CDSCO?

You will need both forms when importing notified medical devices into India.

Situations where both are required:

• Foreign manufacturers exporting to India

• Indian importers sourcing devices internationally

• Distributors dealing in regulated devices

Important note:

First, you must file MD-14. After that, CDSCO evaluates your application and issues MD-15.

MD 14 vs MD 15 CDSCO Process (Step-by-Step)

Here is a visual representation of MD 14 vs MD 15 CDSCO process:

This diagram simplifies the CDSCO import licensing process for better understanding and faster decision-making.

Now let’s understand the complete process of CDSCO MD 15 License.

Step 1: Appoint an Indian Authorized Agent

Foreign manufacturers must appoint a local representative.

Step 2: Prepare documentation

You need:

• Free Sale Certificate (FSC)

• ISO certification

• Device master file

• Power of Attorney

Also read our detailed guide on MD-14 documents checklist.

Step 3: Submit MD-14

Upload all documents on the Sugam portal.

Step 4: Review by CDSCO

CDSCO evaluates technical and regulatory compliance.

Step 5: Grant of MD-15

After approval, CDSCO issues the import license.

Common Mistakes in MD 14 CDSCO Applications

Many applications face delays or rejection due to avoidable errors.

Avoid these mistakes:

• Incorrect device classification

• Incomplete documentation

• Errors in Power of Attorney

• Missing labeling compliance

Moreover, even small mistakes can delay approval by weeks.

Check our CDSCO Medical Device classification guide to understand Device Classification.

MD 14 vs MD 15 CDSCO: Timeline & Approval Duration

The timeline depends on device class and documentation quality.

Typical timeline:

• Class A & B: 30–45 days

• Class C & D: 60–90 days

However, incomplete applications can significantly increase processing time.

CDSCO MD 14 & MD 15 for Foreign Manufacturers

Foreign manufacturers must follow additional requirements.

Key requirements:

• Appoint Indian Authorized Agent

• Submit apostilled documents

• Ensure compliance with Indian labeling rules

Why this matters:

Without proper documentation, CDSCO may reject the application.