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Looking to start a medical device manufacturing unit in India? Obtaining a CDSCO Medical Device Manufacturing License is a legal requirement under the Medical Devices Rules, 2017. This license ensures your facility meets the necessary quality and safety standards laid out by the Central Drugs Standard Control Organisation (CDSCO). The process involves classification of devices, submission of Form MD-5 or MD-9, site inspection, and compliance with Good Manufacturing Practices (GMP). At Agile Regulatory, we assist manufacturers with end-to-end licensing support—right from documentation to regulatory approvals.