The medical device industry in India is rapidly growing, creating opportunities for distributors and wholesalers. However, operating legally in this sector requires proper licensing. The MD-42 License is a mandatory certification for businesses involved in the distribution of medical devices. In this blog, we’ll cover everything you need to know about MD-42 License Registration, Medical Device Distribution License, and the CDSCO MD-42 process in India.

What is an MD-42 License?

The MD-42 License is issued by the Central Drugs Standard Control Organization (CDSCO) and authorizes businesses to wholesale medical devices in India. This license ensures that distributors comply with safety, quality, and storage standards as prescribed by the government.

Without an MD-42 License, distributing medical devices is considered illegal and can attract penalties, fines, or closure of operations.

Why is MD-42 License Registration Important?

Obtaining an MD-42 License Registration in India is crucial for multiple reasons:

  1. Legal Compliance: Ensures that your business adheres to CDSCO regulations.

  2. Market Credibility: Builds trust with manufacturers, hospitals, and healthcare providers.

  3. Safe Distribution: Guarantees that medical devices are stored and transported according to quality norms.

  4. Business Expansion: A valid license is often required to sign contracts with suppliers and medical institutions.

Who Needs an MD-42 License?

The Medical Device Distribution License is required for:

  • Businesses engaged in the wholesale distribution of medical devices.

  • Distributors operating across states in India.

  • Companies storing and supplying medical devices to hospitals, clinics, or other healthcare providers.

Even small distributors or startups must obtain the CDSCO MD-42 license before starting operations.

Steps to Obtain MD-42 License in India

The MD-42 License Registration process involves the following steps:

  1. Check Eligibility: Ensure your storage facilities meet CDSCO guidelines, including proper temperature control and hygiene standards.

  2. Prepare Documentation: Required documents typically include:

    • Business incorporation documents

    • Proof of premises

    • Qualified personnel details

    • SOPs for handling and storing medical devices

  3. Application Submission: Submit Form MD-42 to CDSCO or the respective State Licensing Authority.

  4. Inspection: The authorities may inspect your warehouse or distribution facility to verify compliance.

  5. License Issuance: Once the inspection and verification are complete, you will receive your MD-42 License, authorizing legal medical device distribution.

Benefits of Having an MD-42 License

  • Operate legally and avoid penalties.

  • Strengthen your brand credibility in the healthcare market.

  • Enable partnerships with major medical device manufacturers.

  • Facilitate smooth distribution across India.

CDSCO MD-42 Guidelines

The CDSCO MD-42 guidelines ensure that distributors maintain quality control throughout the supply chain. Key points include:

  • Proper storage conditions for different categories of medical devices.

  • Employing qualified personnel for handling and dispatch.

  • Maintaining records of distribution and inventory.

Compliance with CDSCO regulations ensures that your business operates ethically and safely.

Conclusion

EVTL India is one of the leading BIS Consultant in India, helping manufacturers obtain their BIS licences hassle-free.For any business looking to distribute medical devices in India, obtaining an MD-42 license is not optional—it is mandatory. From ensuring legal compliance to building trust with clients, the MD-42 License Registration in India is essential for success in the medical device sector.