In this guide, you will learn:

• How to get CDSCO Medical Device import license

• Complete medical device import process in India

• CDSCO Medical Device Import License (MD 14, MD 15) process step-by-step

• Required documents for CDSCO Medical Device Import License (MD 14, MD 15)

• Timeline and compliance requirements for CDSCO Medical Device Import License (MD 14, MD 15)

• Role of an Indian Authorized Agent in CDSCO Medic Import License (MD 14, MD 15)

Whether you are an Indian importer or a foreign manufacturer, this article explains everything in clear and practical terms.

What is CDSCO Medical Device Import License?

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017.

If a company wants to import medical devices into India, it must obtain:

• MD14 – Application for Medical Device Import License

• MD15 – Medical Device Import License issued by CDSCO

Without MD15 approval, customs authorities will not clear the products.

Who Needs a CDSCO Medical Device Import License (MD 15)?

You need a CDSCO import license if:

• You are importing medical devices into India

• You are a foreign manufacturer selling devices in India

• You appoint an Indian Authorized Agent

• Your device falls under Class A, B, C, or D category

Additionally, even diagnostic kits, surgical instruments, and electronic medical devices require registration if they fall under notified categories. 

How to Get CDSCO Medical Device Import License (MD 15) in India (Step-by-Step)

Below is the complete medical device import license process in India.

Step 1: Determine Device Classification

First, identify whether your device falls under:

• Class A (Low risk)

• Class B (Low moderate risk)

• Class C (Moderate high risk)

• Class D (High risk)

The classification determines review complexity and approval timeline.

Step 2: Appoint an Indian Authorized Agent (For Foreign Manufacturers)

Foreign manufacturers must appoint an Indian Authorized Agent who:

• Holds a valid wholesale drug license

• Acts as the official liaison with CDSCO

• Submits MD14 application

• Responds to regulatory queries

Without an Authorized Agent, CDSCO will not process the application.

If you are a foreign manufacturer looking to appoint an Indian Authorized Agent for CDSCO import licensing, you can explore our CDSCO Medical Device Import License Consultant in India.

Step 3: Prepare Documentation for MD14 Application

You must prepare the following documents:

• Covering letter

• Power of Attorney

• Free Sale Certificate

• ISO 13485 certificate

• CE certificate (if applicable)

• Device Master File

• Plant Master File

• Label and IFU copies

• Undertaking and declarations

Proper documentation reduces query risks significantly.

Step 4: Submit MD14 Application via CDSCO SUGAM Portal

Next, the Indian Authorized Agent submits Form MD14 online through the SUGAM portal.

At this stage:

• Government fees must be paid

• All technical documents must be uploaded

• Accuracy is critical

Even small mistakes can delay approval.

Step 5: CDSCO Review & Query Handling

After submission:

• CDSCO reviews technical documentation

• Authorities may raise queries

• Clarifications must be submitted within the deadline

Proactive query management improves approval speed.

Step 6: Grant of MD15 Import License

If CDSCO approves the application:

• MD15 import license is issued

• License remains valid perpetually (subject to retention fee)

• Importer can start commercial imports

This completes the CDSCO MD15 process.

CDSCO MD15 Process Timeline

The timeline depends on device class:

• Class A/B: 3–6 months

• Class C/D: 6–9 months

However, incomplete documentation can extend timelines.

Therefore, professional regulatory preparation significantly reduces delays.

Documents Required for CDSCO MD14, MD 15 Import License

Here is a simplified checklist:

1. Power of Attorney from Manufacturer

2. ISO 13485 Certificate

3. Free Sale Certificate

4. CE Design Certificate (for higher classes)

5. Device Master File

6. Plant Master File

7. Labeling as per MDR 2017

8. Wholesale License of Authorized Agent

You should prepare documents exactly as per CDSCO format to avoid rejection.

Government Fees for CDSCO MD 14, MD 15 Import License

Government fees depend on:

• Device class

• Number of Devices

• Manufacturing site

Additionally, official CDSCO fee applies per manufacturing site and per device.

Common Reasons for Delay in CDSCO Medical Device Import License (MD 15)

Many applications face delays due to:

• Incorrect device classification

• Incomplete Device Master File

• Improper labeling compliance

• Weak clinical data

• Inexperienced query response

Therefore, structured regulatory planning is essential.

To avoid regulatory delays, many importers work with experienced CDSCO regulatory consultants who manage documentation and query handling end-to-end.

Role of Indian Authorized Agent in CDSCO Medical Device Import License (MD 15) Process

The Indian Authorized Agent:

• Submits application

• Maintains regulatory records

• Handles post-approval compliance

• Manages retention fees

• Communicates with CDSCO

Moreover, the agent carries legal responsibility for compliance in India.

Choosing a qualified regulatory partner ensures long-term compliance security.

Can Foreign Manufacturers Apply Directly for CDSCO Import License for Medical Device (MD 15)?

No. Foreign manufacturers cannot directly apply.

They must appoint:

• An Indian Authorized Agent

• A licensed wholesale distributor

This requirement ensures regulatory accountability inside India.

Post-Approval Compliance Requirements For Imported Medical Device

After receiving MD15:

• Maintain updated documentation

• Report adverse events

• Pay retention fees every five years

• Update license for major changes

Failure to comply may lead to suspension.