MD-42 Medical Device
Registration Certificate
Secure the fundamental legal authorization to sell, stock, exhibit, and distribute medical devices and IVDs across the Indian market.
Consult Our CDSCO Experts
What is the MD-42 License?
For any business—whether a retailer, wholesaler, or stockist—involved in the sale, stocking, exhibition, or distribution of medical devices (including in-vitro diagnostics) in India, the MD-42 license is a mandatory legal requirement. Officially known as the Medical Device Registration Certificate, it ensures full compliance with the Medical Devices Rules, 2017.
Key Aspects:
- Issuing Authority: Granted by the State Licensing Authority (SLA), often the State FDA, in the respective state or union territory.
- Application Form: Businesses apply using Form MD-41.
- Validity: The certificate is valid for a period of five years and requires periodic retention fee payments.
- Broad Scope: Covers a comprehensive range of devices, from simple healthcare products to advanced diagnostics.
Why is it Crucial for Your Business?
Mandatory Requirement
Without this license, engaging in any form of medical device sales, stocking, or distribution in India is strictly illegal.
Legal Authorization
It formally grants your business the essential legal right to operate within the medical device supply chain.
Regulatory Compliance
Holding an MD-42 demonstrates to partners, manufacturers, and authorities your strict adherence to the Medical Devices Rules, 2017.
Expert MD-42 Assistance
Navigating state-level FDA requirements can be intricate. Our expert consultants streamline your MD-41 application to ensure timely issuance of your MD-42 license.
- Flawless Form MD-41 preparation
- Comprehensive document compilation
- Active SLA liaison & follow-up