Manufacturing Archives - HL Associates https://hl-associates.in/blog/tag/manufacturing CDSCO, US FDA, EU MDR & UKCA Regulatory Consultants Thu, 29 Oct 2026 09:22:44 +0000 en-US hourly 1 https://wordpress.org/?v=7.1.4 Obtaining MD-09: Manufacturing Class C & D Devices in India https://hl-associates.in/blog/cdsco-class-c-d-manufacturing-md-09 https://hl-associates.in/blog/cdsco-class-c-d-manufacturing-md-09#respond Tue, 28 Apr 2026 09:00:00 +0000 https://hl-associates.in/blog/cdsco-class-c-d-manufacturing-md-09/ Deep dive into the stringent requirements for setting up manufacturing facilities for high-risk medical devices in India.

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]]> The Central Licensing Authority Oversight

Unlike Class A & B devices which are licensed by the State Licensing Authorities (SLA), the manufacturing licenses for Class C and D devices (Form MD-09) are issued directly by the Central Licensing Authority (CLA) at CDSCO headquarters.

Joint Inspections and Plant Master Files

The application process demands the submission of a highly detailed Plant Master File (PMF) outlining the HVAC systems, cleanroom validations, and water systems. Furthermore, before a license is granted, a rigorous joint inspection is conducted by CDSCO inspectors and notified bodies to physically verify compliance with the Fifth Schedule (Quality Management System) of the MDR 2017.

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