How To Apply Manufacturing License For Medical Device In India? - Medwisdom

Applying for a manufacturing license for medical devices in India involves compliance with the Medical Device Rules, 2017 under the Drugs and Cosmetics Act. At Medwisdom, we guide manufacturers through the step-by-step process including classification of the device (Class A, B, C, or D), preparation of required documentation such as Device Master File (DMF), Plant Master File (PMF), and Quality Management System (QMS) adherence. We assist in online registration through the CDSCO SUGAM portal, liaison with State and Central Licensing Authorities, and ensure timely submission and follow-ups. Our regulatory experts streamline the entire process for a smooth and compliant license acquisition.
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