How to Apply for MD-42 License in India: Step-by-Step Process (2025)

Author: Psr Compliance

What Is the MD-42 License?

The MD-42 License is a mandatory certificate for manufacturers and importers of Class C and Class D medical devices in India. These classes cover devices with moderate to high risk, such as surgical implants, diagnostic equipment, and life-supporting instruments.

The Central Drugs Standard Control Organisation (CDSCO) grants the MD-42 License after a thorough evaluation of your manufacturing facility, quality management system, and product compliance.

Who Should Obtain an MD-42 License?

You need an MD-42 License if you are:

  • Manufacturing Class C or Class D medical devices in India.

  • Importing Class C or Class D devices into India from foreign manufacturers.

Failure to obtain the license before commercial activities can lead to penalties, cancellation of permissions, and seizure of products.

Key Documents Required

While applying for the MD-42 License, you must prepare several documents, including:

  • Covering Letter with application details
  • Manufacturing Site Master File
  • Device Master File
  • Quality Management System (ISO 13485) Certificate
  • Free Sale Certificate (in case of import)
  • Undertaking of compliance with Medical Device Rules, 2017
  • Details of the qualified technical staff

It is advisable to prepare accurate and up-to-date documentation to avoid delays in approval.

Step-by-Step Application Process

Here’s a simplified outline of how to obtain an MD-42 License:

  1. Create an SUGAM Portal Account:

    Register on CDSCO’s SUGAM portal, the official online platform for licensing.

  2. Submit Application Form:

    • For manufacturing: Apply in Form MD-7.

    • For import: Apply in Form MD-14.

  3. Upload Documents:

    Attach all the required documents, including technical dossiers and undertakings.

  4. Pay Fees:

    Pay the government fee applicable to your device class and type of application.

  5. Inspection & Evaluation:

    CDSCO will schedule a site inspection (in case of manufacturing) to assess compliance.

  6. Grant of License:

    If everything is in order, the licensing authority will issue the MD-42 License in Form MD-9 for manufacturers or Form MD-15 for importers.

Validity and Renewal

The MD-42 License is valid perpetually, subject to payment of renewal retention fees every five years and continued compliance with regulations.

Why Professional Assistance Matters

The process can be technical and time-consuming. Engaging an experienced compliance consultant can help:

  • Avoid errors in your documentation.

  • Prepare for facility audits.

  • Track your application status.

  • Ensure timely renewals.

For more detailed information and professional assistance to obtain your MD-42 License, visit: