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10-Jul-2025

MD-42 License Requirements, Process, and Benefits Explained

Summary

The MD-42 License, issued by India’s Central Licensing Authority, is mandatory for manufacturing Class C and D medical devices like stents and implants. To obtain it, manufacturers must have ISO 13485-compliant facilities, qualified staff, and follow GMP. The application involves submitting detailed documentation via the CDSCO SUGAM portal, paying fees, and passing inspections. Valid for 5 years, the MD-42 License ensures regulatory compliance, builds trust, and enables market access. Expert assistance can simplify the process and help avoid delays or rejections.
Editor: PSR Compliance Last Updated: 11-Jul-2025

What is an MD-42 License?

An MD-42 license is granted by the Central Licensing Authority (CLA) to manufacturers of Class C and D medical devices. This license ensures your products meet strict safety, quality, and performance standards as mandated by the Drugs and Cosmetics Act, 1940.

Who Needs an MD-42 License?

Any entity intending to manufacture or assemble Class C and D medical devices for sale or distribution in India must obtain an MD-42 license. This requirement applies to:

  • Indian manufacturers

  • Importers who wish to assemble devices locally

  • Companies engaged in contract manufacturing of regulated devices

Eligibility Criteria

To be eligible for an MD-42 license, your manufacturing facility must:

  • Be equipped with appropriate infrastructure

  • Implement a robust Quality Management System (QMS), usually ISO 13485

  • Employ qualified technical staff with relevant experience

  • Follow Good Manufacturing Practices (GMP)

Step-by-Step Application Process

  1. Preparation and Documentation

    • Prepare the necessary documents, including:

      • Site Master File

      • Device Master File

      • Quality policy and procedures

      • Details of machinery and equipment

      • Testing protocols

  2. Online Application

    • Submit your application through the CDSCO’s online portal (SUGAM).

    • Pay the applicable government fees.

  3. Audit and Inspection

    • The Central Licensing Authority will review your documents.

    • An on-site inspection is conducted to verify compliance with QMS and GMP standards.

  4. Grant of License

    • If the inspection is satisfactory, the MD-42 license is issued.

    • The license is valid for five years, subject to periodic compliance audits.

Key Benefits of MD-42 License

  • Market Legitimacy: Your products are legally approved for manufacturing and sale in India.

  • Consumer Trust: Demonstrates adherence to strict safety and quality standards.

  • Business Growth: Enables participation in government tenders and exports.

  • Regulatory Compliance: Protects your business from legal penalties and shutdowns.

Common Challenges and Solutions

  • Complex Documentation: Engage professional consultants to prepare accurate dossiers.

  • Infrastructure Gaps: Upgrade facilities to meet Class C and D standards before applying.

  • Delayed Inspections: Stay proactive with follow-ups and timely compliance responses.

Why Choose Expert Assistance?

Navigating the MD-42 licensing process can be overwhelming. Regulatory experts like PSR Compliance help businesses streamline applications, conduct pre-audit checks, and ensure smooth coordination with CDSCO. With professional guidance, you can save time, reduce the risk of rejection, and focus on your core manufacturing operations.

Conclusion

Securing an MD-42 license is a crucial step for any medical device manufacturer targeting the Indian market. It reflects your commitment to quality and patient safety. Whether you’re a startup or an established company, staying compliant with the Medical Device Rules, 2017 is non-negotiable.

To learn more about MD-42 license requirements and expert support, visit:
https://www.psrcompliance.com/blog/md-42-license-in-india