A New Regulatory Paradigm for Medical Devices in India

Posted 12 December 2017 By Dushyant Kumar, MPharm, RAC, Vibhu Yadav, MPharm, Nancy Mathewson, Esq

placeholder+image This article explains medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes.

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Categories: Medical Devices, Features, India, IMDRF, GHTF, ISO

Tags: Draft Medical Device Rules 2017, GHTF, Bureau of Indian Standards, BIS

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