The MD 14 License is essential for businesses engaged in manufacturing Class A and B medical devices in India. Issued under the Medical Device Rules, 2017 by the State Licensing Authority, this license ensures that manufacturing units meet safety, quality, and compliance standards. To obtain the MD 14 License, applicants must submit documents like site master files, device master files, plant layout, and quality management system details. At Agile Regulatory, we assist manufacturers with end-to-end support for documentation, application filing, and coordination with authorities to streamline the approval process. Ensure your compliance and start manufacturing legally with expert guidance.

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