MD-42 Certificate

For any business involved in the sale, stocking, exhibition, or distribution of medical devices, including in-vitro diagnostics, within India, the MD-42 license is a fundamental and mandatory legal requirement. Officially known as the Medical Device Registration Certificate, this document is your authorization to operate legally in the Indian market, ensuring full compliance with the Medical Devices Rules, 2017.

What is the MD-42 License?

The MD-42 license is the essential regulatory approval granted by the State Licensing Authority (often the State FDA). It specifically permits retailers, wholesalers, and stockists to legally handle and distribute medical devices across India.

Why is the MD-42 License Crucial for Your Business?

Obtaining the MD-42 license is not just a formality; it’s a critical step for legal and compliant operation:

• Legal Authorization: It grants your business the essential legal right to sell, stock, exhibit, and distribute a wide range of medical devices.
• Mandatory Requirement: Without this license, engaging in any form of medical device sales or distribution in India is illegal.
• Ensures Regulatory Compliance: Holding an MD-42 license demonstrates your adherence to the stringent regulatory standards set forth in the Medical Devices Rules, 2017.

Key Aspects of the MD-42 License

• Issuing Authority: The State Licensing Authority (SLA) in the respective state or union territory issues the MD-42 license.
• Validity: The certificate is valid for a period of five years and can be efficiently renewed by paying the prescribed retention fee.
• Application Process: Businesses apply for this license using Form MD-41, and upon approval, the certificate is issued in Form MD-42.
• Broad Scope: This license covers a comprehensive range of devices, from those used in healthcare and diagnostics to other related medical fields.

How MDR Consultants Can Assist You with Your MD-42 License

Navigating the application process for an MD-42 license can be intricate. Our team of expert MDR consultants can simplify this process for you by providing:

1. Application Preparation: Guiding you through the completion of Form MD-41, ensuring all details are accurate and complete.
2. Document Compilation: Assisting in gathering and organizing all necessary supporting documents.
3. Submission & Follow-up: Managing the submission of your application to the relevant State Licensing Authority and diligently following up to ensure timely processing and issuance of your MD-42 license.

Ensure your medical device distribution business operates legally and compliantly in India. Partner with us to streamline your MD-42 license application.