Category: Regulatory

CDSCO Import License (MD-15) & Test License (MD-16): The Complete Guide to India Market Entry

CDSCO Medical Device Compliance, Import License MD-15, and Test License approval for market entry in India.

Deciphering the CDSCO Forms: Import License (MD-15), Test License (MD-16), and the Sugam Portal

The CDSCO registration process is centralized through the official Sugam Portal, which is the dedicated online platform for all applications. This process revolves around specific forms required for various purposes, including obtaining the Import License (MD-15) and Test License (MD-16). Confusion over these forms is the number one reason for regulatory setbacks.

It is also important to note the National Single Window System (NSWS) (https://www.nsws.gov.in/). This initiative aims to streamline and simplify investment and business clearances across various Indian government departments, potentially integrating future CDSCO-related approvals and making the entire process more efficient for foreign investors and domestic manufacturers.

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