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A New Regulatory Paradigm for Medical Devices in India By Dushyant Kumar, MPharm, RAC, Vibhu Yadav, MPharm, Nancy Mathewson, Esq - Published 12 December 2017

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

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

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