Overview of medical device regulations in India
Before manufacturers of medical and in vitro diagnostic (IVD) devices can sell in India, they need to engage an importer to register their products with the Central Drugs Standard Control Organization (CDSCO), which will issue an import license.
India's medical device regulatory approval process
The chart illustrates the CDSCO approval process per device classification in India and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration is provided here.
Step 1
Determine the classification of your device according to the CDSCO’s published classification lists.
Step 2
Appoint an India Authorized Agent to manage your device registration and interact with the CDSCO on your behalf.
Step 3
Prepare the device application and supporting documents for submission to the CDSCO.
Step 4
Pay the application fee. The CDSCO reviews the application and may request additional information.
Step 5
Upon CDSCO approval, they will issue an import license for your device.
Log in to RAMS to view the chart
This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for India when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.
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