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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

Regulatory Harmonization Initiatives By Mukesh Kumar, RAC, Eliane Barras, MSc, Lewis Lau, RAC - Published 09 May 2017

This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards.

Categories: Features, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, APEC, GHTF, ICH, IMDRF, ISO, OECD, WHO, Biologics and biotechnology, Compliance, Drugs, Medical Devices

Tags: Harmonization

Former FDA and NIH Heads Call for Regulatory Harmonization By Zachary Brennan - Published 11 May 2016

Former US Food and Drug Administration (FDA) commissioner Margaret Hamburg and former National Institutes of Health (NIH) director Elias Zerhouni are calling for more global regulatory drug and device harmonization in an editorial posted Wednesday in Science Translational Medicine.

Categories: News, Africa, Asia, Canada, Europe, US, CDSCO, EMA, FDA, GHTF, Health Canada, ICH, IMDRF, MHRA, WHO, Active pharmaceutical ingredients, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regulatory harmonization, regulatory convergence, Margaret Hamburg, Sanofi

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

Dr. Khoo Teng Chuan, Co-Chair of the RAPS Pan Asia Advisory Committee, Dies at 56 By Zachary Brennan - Published 30 September 2015

Dr. Khoo Teng Chuan, a leader and expert in the pharmaceutical and medical device sectors across Asia, passed away on Tuesday at the age of 56.

Categories: News, Asia, GHTF, IMDRF

Tags: Singapore, Dr Khoo Teng Chuan, J&J, Singapore Clinical Research Institutes

IMDRF Participants Outline Plans for Next Week’s Meeting in Japan By Zachary Brennan - Published 08 September 2015

In anticipation of the International Medical Device Regulators Forum (IMDRF) stakeholders meeting in Japan next week, participating countries’ regulators, trade groups and others have outlined a number of updates they plan to share.

Categories: News, GHTF, IMDRF, Medical Devices

Tags: CDRH, IMDRF, medical devices, device harmonization

IMDRF Proposes QMS Principles for Software as a Medical Device By Michael Mezher - Published 08 April 2015

In recent years, general-purpose devices such as personal computers, smartphones and wearables have enabled the proliferation of “software as a medical device” (SaMD) products.

Categories: News, GHTF, IMDRF, ISO, Manufacturing, Medical Devices, Project management, Quality

Tags: Software as a Medical Device, SaMD, ISO 13845:2003, QMS

Medical Device Industry and Regulator Harmonization Efforts Update By Susan Hibbeln - Published 23 April 2014

As more countries formalize medical device regulations, international regulatory and quality systems professionals must continually refine and harmonize their internal processes for registration of medical device products and adherence to international quality standards.

Categories: Features, GHTF, IMDRF

Tags: RPS, MDSAP, harmonization, medical device

GHTF Says Final Goodbyes, Shutters Website By Alexander Gaffney, RF News Editor - Published 28 November 2012

Categories: GHTF, IMDRF

Tags: Closed, Guidances, harmonization, website, medical device

Regulators, Industry Discuss Potential Impact of IMDRF By Alexander Gaffney, RF News Editor - Published 30 October 2012

Categories: Under RAPS, GHTF, IMDRF

Tags: Minor, Trautman, Ward, harmonization, Standards, convergence, medical device

GHTF Releases Adverse Event Report Standard for Pre-Clinical Trials By Alexander Gaffney - Published 13 August 2012

Categories: GHTF

Tags: Pre-Market, Reporting, Adverse Event, Latest News, clinical trials

GHTF Releases Guidance on Adverse Event Data Reporting Standard By Alexander Gaffney - Published 02 August 2012

Categories: GHTF

Tags: N87:2012, SG2, N54:2006, XML, Adverse Event Reports, AER, Latest News

GHTF Changes Definitions of 'Medical Device' and 'IVD' By Alexander Gaffney - Published 24 May 2012

Categories: GHTF

Tags: Accessory, Definition, Final Document, Latest News, IVD, medical device

GHTF Proposes New Harmonization of Medical Device Audits By Alexander Gaffney - Published 24 April 2012

Categories: GHTF

Tags: NGS, RAEIF, Nonconformity Grading System, QUality Management System, SG3(PD)/N19, SG3, Standard, Latest News, QMS, proposed, medical device

IMDRF Announces Open Stakeholder Meeting By Alexander Gaffney - Published 26 March 2012

Categories: GHTF, IMDRF

Tags: Stakeholder, Meeting, Latest News, australia, medical device

FDA Launches Pilot Program for ISO 13485:2003 Audit Report Submissions By Alexander Gaffney - Published 16 March 2012

Categories: FDA, CBER, CDRH, GHTF, ISO

Tags: 13485:2003, Pilot, Latest News, guidance, program

IMDRF Concludes Inaugural Meeting, Looks to Assume GHTF Duties By Alexander Gaffney - Published 15 March 2012

Categories: GHTF, IMDRF

Tags: harmonization, Meeting, Latest News, medical device

GHTF Releases Proposed Changes to SG5 Clinical Performance Studies for IVDs By Alexander Gaffney - Published 02 February 2012

Categories: GHTF

Tags: Proposed Document, Clinical Performance Studies, SG5, Latest News, IVD

Will Global Medical Device Trade Improve With Accredited ISO 13485 Certification? By Grant Ramaley - Published 01 December 2011

One of the things that never really changes in the field of medical device compliance is how we look at solving our trade problems. For decades, we heard, "Accepted once, accepted everywhere. Harmonization is the answer." But the collapse of the Global Harmonization Task Force (GHTF) and much food fight-style banter at the World Trade Organization (WTO) mean too little progress has been achieved in serving up solutions that genuinely improve medical device trade. The main problem with harmonization within the public health protection sphere stems from the sincere obligations of regulators to protect their own people. As a result, what happened at GHTF can be seen as a movement away from harmonization, as each nation creates a custom version of the harmonized guidance.

Categories: GHTF

Tags: Perspective, harmonization, regulators, accreditation, IAF, ISO 13485, global, medical device