Search Results for Medical Device Single Audit Program

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MDSAP Update: Canada's 2019 Deadline Still on Track By Michael Mezher - Published 11 September 2017

Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP).

Categories: News, Japan, Canada, Latin America and Caribbean, Oceania, US, Anvisa, FDA, Health Canada, MHLW, PMDA, TGA, Medical Devices

Tags: MDSAP, Medical Device Single Audit Program

FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP By Michael Mezher - Published 18 December 2015

The US Food and Drug Administration (FDA) says it is discontinuing one of its audit-sharing pilots ahead of the launch of a "fully operational" Medical Device Single Audit Program (MDSAP) in 2017.

Categories: News, US, CDRH, GHTF, IMDRF, Audit, Medical Devices, Postmarket surveillance, Regulatory strategy

Tags: MDSAP, Medical Device Single Audit Program, ISO 13485, Kim Trautman

MDSAP to Continue Past Pilot Phase in 2016 By Zachary Brennan - Published 28 October 2015

Put simply, the Medical Device Single Audit Program (MDSAP) isn't going anywhere when its pilot project ends in 2016, Kim Trautman, associate director, international affairs of the Office of the Center Director of CDRH at the the US Food and Drug Administration (FDA), told attendees of RAPS' Regulatory Convergence on Wednesday.

Categories: News, Asia, Canada, Europe, Oceania, US, Anvisa, EC, FDA, GHTF, Health Canada, IMDRF, MHLW, PMDA, TGA, WHO, Audit, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence

Tags: MDSAP, medical device single audit program, FDA pilot program, US FDA, TGA, PMDA

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

Brazil Expedites Device Imports By Louise Zornoza, RegLink - Published 15 April 2014

Categories: Regulatory Update, Anvisa

Tags: Medical Device Single Audit Program, MDSAP, CBPF, Import, brazil, cGMP, medical device