Search Results for GHTF

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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

IMDRF Offers New Guideline on Adverse Event Reporting By Zachary Brennan - Published 10 April 2017

As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday published a new final guideline on a harmonized terminology for reporting such events.

Categories: News, Asia, Canada, Europe, US, IMDRF, Compliance, In vitro diagnostics, Medical Devices, Postmarket surveillance, Quality

Tags: adverse events for medical devices, IMDRF guideline, GHTF

Medical Device Audit Program Needs More Industry Involvement, Report Says By Zachary Brennan - Published 21 September 2015

A mid-pilot report on the international Medical Device Single Audit Program shows some progress, though work still needs to be done, particularly in terms of attracting industry participants before the expected operational launch in 2017, a recent report says.

Categories: News, Asia, Canada, Europe, US, Audit, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Medical Device Single Audit Program, IMDRF, GHTF, Canadian Medical Device Conformity Assessment System, medical device manufacturers