Obtaining MD-09: Manufacturing Class C & D Devices in India
HL Associates Team
CDSCO Consultants
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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