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