What are the key requirements for obtaining a medical device license in India?

To obtain a medical device license in India, key requirements include submitting a detailed application to the Central Drugs Standard Control Organization (CDSCO), providing product specifications, manufacturing details, clinical data, and ISO certifications. Applicants must also ensure compliance with Medical Device Rules, 2017, and submit proof of quality management systems. Regulatory fees and labeling requirements must also be fulfilled. 2025-8-30 14:27 

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