India’s medical device sector is expanding at a fast pace, supported by rising healthcare needs, local manufacturing, and growing imports from global manufacturers. However, bringing medical devices into India is not as simple as shipping products across borders. Every imported device must comply with India’s regulatory framework, which is governed by the Central Drugs Standard Control Organization (CDSCO).

One of the most important regulatory requirements is obtaining a Medical Device Import License. Below is a clear explanation of why this license is required, how the process works, and the role of key forms such as MD-14 and MD-15.

Why Is an Import License Required?

The CDSCO functions under the Ministry of Health and Family Welfare and oversees the import, manufacture, and sale of medical devices in India. As per the Medical Device Rules (MDR), 2017, medical devices are classified based on risk into:

  1. Class A
  2. Class B
  3. Class C
  4. Class D

For Class A (sterile), Class B, Class C, and Class D devices, an import license is mandatory. This ensures that all devices entering the Indian market meet prescribed standards of safety, quality, and performance, protecting both patients and healthcare professionals.

CDSCO Import License (MD-15): Fees, Validity & Renewal Made Simple

Once you understand how to apply for a CDSCO Import License, the next thing most manufacturers ask is—how much does it cost, and how long does the license last? Here’s a clear breakdown in plain language.

How Much Does a CDSCO Import License Cost?

The fee for an MD-15 Import License depends on two things:

  1. The risk class of the device, and
  2. The number of manufacturing sites and products.

Fees for Medical Devices

  1. Class A (Non-Sterile, Non-Measuring): No government fee
  2. Class A: USD 1,000 per manufacturing site + USD 50 per device
  3. Class B: USD 2,000 per site + USD 1,000 per device
  4. Class C: USD 3,000 per site + USD 1,500 per device
  5. Class D: USD 3,000 per site + USD 1,500 per device

Fees for In-Vitro Diagnostic (IVD) Devices

  1. Class A (Non-Sterile, Non-Measuring): No government fee
  2. Class A: USD 1,000 per site + USD 10 per IVD
  3. Class B: USD 1,000 per site + USD 10 per IVD
  4. Class C: USD 3,000 per site + USD 500 per IVD
  5. Class D: USD 3,000 per site + USD 500 per IVD

How Long Is the MD-15 License Valid?

  1. The CDSCO Import License is valid for 5 years from the date it is issued.
  2. This rule comes under the Medical Device Rules, 2017.
  3. To continue importing devices into India, the license must be renewed every five years.

What Is Required for License Renewal?

When it’s time to renew, CDSCO asks for updated information to ensure continued compliance. This usually includes:

  1. A renewal application
  2. Copies of existing import licenses
  3. Updated product and sales details
  4. Post-market surveillance and vigilance reports
  5. A valid ISO 13485 certificate
  6. Payment of the applicable retention fee

Important note:
The main import license and all related endorsements must be renewed together, based on the original approval date of the base license.

Retention Fees: What You Need to Know

  1. The retention fees are the same as the original application fees
  2. Fees depend on the device class and number of sites/devices
  3. Late payment attracts penalties, so renewing on time is essential

Once CDSCO reviews and accepts the renewal application, a Retention Certificate is issued. This ensures that your import license remains active and valid—unless it is cancelled or voluntarily surrendered.

Are All Classes of Medical Devices Allowed to Be Imported into India?

Yes. India permits the import of medical devices across all four risk categories—Class A, Class B, Class C, and Class D. However, the regulatory requirements increase with the level of risk associated with the device, as prescribed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017.

Each class follows a different approval pathway to ensure patient safety, product quality, and regulatory compliance.

Medical Device Classes and Import Requirements in India

S. No.

Device Class

Risk Level

Examples of Imported Devices

Regulatory Requirements

1

Class A

Low Risk

Thermometers, stethoscopes, tongue depressors

Basic registration and documentation; comparatively faster approval process

2

Class B

Low to Moderate Risk

Digital BP monitors, suction machines, infusion pumps

Registration along with essential technical and quality documentation

3

Class C

Moderate to High Risk

X-ray systems, anesthesia machines, orthopedic implants

Detailed technical files, safety data, and supporting clinical evidence

4

Class D

High Risk

Heart valves, pacemakers, ventilators, dialysis machines

Most stringent regulatory review, including extensive clinical validation and risk assessment

Regulatory Process for Importing Medical Devices into India

Importing medical devices into India involves a structured regulatory process governed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules (MDR), 2017. Below is a step-by-step overview of the regulatory pathway that manufacturers and importers must follow.

Step-by-Step Regulatory Process

S. No.

Step

Description

1

Check Device Notification

First, confirm whether your product falls under the list of medical devices notified by CDSCO. Only notified devices require registration and licensing.

2

Determine Device Classification

Based on intended use and risk level, the device is classified as Class A, B, C, or D. Higher-risk devices are subject to stricter regulatory scrutiny.

3

Appoint an Indian Authorized Agent

Foreign manufacturers must appoint an Indian Authorized Agent who is properly licensed and registered with CDSCO to represent them in India.

4

Apply for Import License (Form MD-14)

The Authorized Agent submits Form MD-14 to CDSCO on behalf of the foreign manufacturer to seek permission to import the medical device.

5

Prepare Required Documentation

All technical, regulatory, and legal documents must be compiled as per CDSCO requirements.

6

Submit Application via SUGAM Portal

The complete application is filed online through the CDSCO SUGAM portal.

7

CDSCO Review & Queries

CDSCO reviews the application and may raise queries or request clarifications. Timely responses are crucial to avoid delays.

8

Grant of Import License (Form MD-15)

Once CDSCO is satisfied, it issues Form MD-15, allowing the legal import and sale of the medical device in India.

9

Post-Import Compliance

Importers must maintain records, manage complaints, provide after-sales support, and report adverse events as required.

Documentation Required for Import of Medical Devices in India

Documents for CDSCO Import License

(Form MD-14 & Form MD-15)

  1. Covering Letter
  2. Power of Attorney (PoA)
  3. Free Sale Certificate (FSC)
  4. Device Master File (DMF)
  5. Plant Master File (PMF)
  6. ISO 13485 Certificate / CE Certificate
  7. Clinical Evaluation Report
  8. Product Label Samples
  9. Test Reports (if applicable)
  10. Declaration of Conformity
  11. Instructions for Use (IFU)
  12. Previous Approval Letters (if any)

Documents Required from Indian Importer / Authorized Agent

  1. CDSCO Registration Proof of Authorized Agent
  2. Wholesale Drug License (Form 20B & 21B) or Medical Device License (Form MD-42)
  3. Import Export Code (IEC)
  4. GST Registration Certificate
  5. Company PAN Card
  6. Board Resolution or Authorization Letter
  7. ID Proof of Authorized Signatory

Documents Required for Customs Clearance at Indian Port

  1. Bill of Entry
  2. Commercial Invoice
  3. Packing List
  4. Air Waybill / Bill of Lading
  5. CDSCO Import License (Form MD-15)
  6. Free Sale Certificate & Power of Attorney (copies)
  7. Product Label Samples on Shipment

Frequently Asked Questions (FAQs)

Q. 1. Who is eligible to import medical devices into India?

Ans. Any entity holding a manufacturing license, wholesale license, or Form MD-42 registration certificate under the Medical Device Rules, 2017 can import medical devices into India.

Q. 2. What is the difference between Form MD-14 and Form MD-15?

Ans.  1. Form MD-14 is the application submitted to CDSCO requesting permission to import medical devices.

         2. Form MD-15 is the import license issued by CDSCO after approval of the MD-14 application.

Q. 3. Is an import license required for all medical devices?

Ans. Yes. An MD-15 Import License is mandatory for importing Class A (sterile), Class B, Class C, and Class D medical devices into India.

Q. 4. How long does it take to receive the MD-15 license?

Ans. The process usually takes 3 to 6 months, depending on the device class and completeness of the application.

Q. 5. What is Form MD-42?

Ans. Form MD-42 is a registration certificate issued by the State Licensing Authority that authorizes distributors and retailers to handle, sell, and distribute medical devices, including IVDs, within India.