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India: PSUR Online Submission for Medical Devices/In-Vitro Devices Marketing Authorization (w.e.f 01 April 2024)

Updated: 11 minutes ago

The Circular, PSUR-13011(15)/1/2024-eoffice, was circulated by the Central Drugs Standard Control Organization (CDSCO) regarding the online submission of Periodic Safety Update Reports (PSUR) applications for medical devices or in-vitro devices marketing authorization.


Starting from 01.04.2024, all PSUR application submissions must be submitted via the Online System for Medical Devices as per checklist and any offline, hard copy submission, or other mode will not be processed.


As CDSCO progressively moves towards digitalization, this new mandatory requirement able to streamline the nation’s regulatory submission procedure and proves that India is poised to implement transparent and efficient regulatory compliance systems in line with global standards.

 


Contact us at info@arqon.com for more information.

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