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MDSAP Changes Aim to Reduce Audit Times By Zachary Brennan - Published 30 October 2017

With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits.

Categories: News, Canada, Health Canada, IMDRF, Government affairs, In vitro diagnostics, Medical Devices, Quality

Tags: MDSAP, quality management system audits, medical device audits

IMDRF Consults on Use of Registries to Support Device Approval Decisions By Zachary Brennan - Published 02 October 2017

The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making.

Categories: News, Asia, Canada, Europe, US, IMDRF, In vitro diagnostics, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: registry data and medical devices, medical device data, approval decisions and registries

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

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

IMDRF Offers a Preview of Next Week’s Vancouver Meeting By Zachary Brennan - Published 06 March 2017

Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently.

Categories: News, Asia, Canada, Europe, US, Anvisa, EC, FDA, IMDRF, TGA, WHO, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IMDRF, MDR, IVDR, MDUFA, Cures

IMDRF Advances Three Device Guidelines for Public Consultation By Michael Mezher - Published 18 October 2016

The International Medical Device Regulators Forum (IMDRF) recently advanced three guidance documents intended to provide a harmonized approach to the terminology and codes used in adverse event reporting, methodologies for analyzing registry data and the clinical evaluation of software as a medical device (SaMD).

Categories: News, FDA, IMDRF, PMDA, Medical Devices

FDA Releases Guidance on Software as a Medical Device for Consultation By Michael Mezher - Published 13 October 2016

The US Food and Drug Administration (FDA) on Thursday opened a public consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) developed by the International Medical Device Regulators Forum (IMDRF).

Categories: News, US, FDA, IMDRF, Clinical, Medical Devices

Tags: Software as a Medical Device, SaMD, IMDRF, International Medical Device Regulators Forum

510(k) Third Party Review Program: FDA Offers New Draft Guidance By Zachary Brennan - Published 09 September 2016

The US Food and Drug Administration (FDA) on Friday issued new draft guidance updating the agency’s current thinking on a program used to accredit third parties to review premarket notification (510(k)) submissions for medical devices and recommend the initial classification of certain devices.

Categories: Canada, Europe, US, CDRH, Health Canada, IMDRF, MHLW, TGA, Government affairs, Manufacturing, Medical Devices, Research and development

Tags: 510(k) submissions, medical devices, third-party audits of medical devices, IMDRF, MDSAP

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

Cash-Strapped MHRA Looks to Stay Flexible By Zachary Brennan - Published 27 April 2016

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released its business plan for 2016-17, warning of serious financial troubles, particularly as funding for the regulation of medical devices has declined over the past decade and as it's losing revenue from industry because of changes at the EU level.

Categories: News, Europe, EC, EMA, IMDRF, MHRA, NICE, WHO, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: MHRA funding, Brexit, CAMD, ICMRA, IMDRF

Regulatory Recon: FDA Approves New Renal Cell Carcinoma Drug; Reduced ANVISA Fees for Some Due to Lawsuit (26 April 2016) By Zachary Brennan - Published 26 April 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, Middle East, US, Anvisa, CDSCO, EC, EMA, FDA, Health Canada, IMDRF, MHRA, Biologics and biotechnology, Clinical, Crisis management, Drugs, Government affairs, Labeling, Manufacturing

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

IMDRF Offers Progress Updates at March Meeting By Zachary Brennan - Published 01 April 2016

The ninth meeting of the management committee of the International Medical Device Regulators Forum (IMDRF) took place in Brasília, Brazil, from 8 to 10 March 2016 and included high-level updates on how the group’s seven current work items are progressing and how device regulations are continuing to converge at the international level.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Oceania, US, Anvisa, EC, EMA, FDA, Health Canada, IMDRF, MHLW, PMDA, WHO, Clinical, Compliance, Due Diligence, Government affairs, Manufacturing, Medical Devices, Quality

Tags: IMDRF, medical device regulations, MDSAP, international medical device regulations, medical software

Regulatory Recon: HHS Rejects House Democrats' Push on Drug Prices; More Theranos Quality Questions (8 March 2016) By Zachary Brennan - Published 08 March 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, Latin America and Caribbean, US, CDSCO, EC, EMA, FDA, IMDRF, PMDA, Biologics and biotechnology, Clinical, Drugs, Due Diligence, Government affairs, Manufacturing, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Practical Guidance for Regulatory Professionals on Combination Products By Suzette Roan, JD, John Towns, PhD - Published 05 February 2016

This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities.

Categories: Features, Europe, US, EC, EMA, FDA, ICH, IMDRF, Combination products, Research and development, Submission and registration

Tags: Combination products, Design validation, Risk management, IMDRF

Asia Regulatory Roundup: China Looks to End Regional Variation in Trial Oversight (22 December 2015) By Nick Paul Taylor - Published 22 December 2015

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, ANZTPA, CDSCO, CFDA, IMDRF, Medsafe, MFDS, PMDA, TGA, Biologics and biotechnology, Clinical, Distribution, Drugs, Due Diligence, Government affairs, Manufacturing

Tags: Asia regulatory affairs, CFDA, TGA, CDSCO, PMDA

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

IMDRF Sets New Long-Term Priorities on Pre-Market Review, Post-Market Surveillance of Devices By Zachary Brennan - Published 16 October 2015

The International Medical Device Regulators Forum (IMDRF) says its focus over the next four years will be to hone in on the convergence of regulations across jurisdictions, and in supporting innovation and timely access to safe and effective medical devices, according to a strategic plan unveiled earlier this month.

Categories: News, Asia, Canada, Europe, US, IMDRF, Clinical, Compliance, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: IMDRF, medical device regulations, regulatory convergence, IVD

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

US, Canada Continue to Push for Regulatory Harmonization in the Life Sciences By Alexander Gaffney, RAC - Published 02 September 2014

US and Canadian regulators are continuing to work together to harmonize the way in which they regulate pharmaceuticals, biologics, over-the-counter drugs, medical devices and veterinary products, both governments confirmed in an update this week.

Categories: News, Canada, US, CBER, CDER, CDRH, Health Canada, ICH, IMDRF, Biologics and biotechnology, Over the counter drugs, Prescription drugs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration, Veterinary products

Tags: RCC, Regulatory Harmonization, ICH, PICS, ICDRA, IPRF

Brazilian Device Industry Prepares for eSubmissions By Louise Zornoza, RegLink News - Published 28 August 2014

Brazil's medical device industry should prepare for electronic submissions, Anvisa, Brazil's national regulatory agency, said at a 20 August 2014 meeting.

Categories: News, Latin America and Caribbean, Anvisa, IMDRF, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Brazil, RPS, eSubmission

IMDRF Moves Forward With Effort to Standardize Global Device Submissions By Alexander Gaffney, RAC - Published 14 August 2014

The International Medical Device Regulators Forum (IMDRF) has released two final documents that, once implemented, should make it much easier to get medical device products approved in multiple regions, including the US, EU and Canada.

Categories: News, China, Japan, Canada, Europe, US, IMDRF, In vitro diagnostics, Medical Devices, Submission and registration

Tags: RPS, Regulated Product Submission, Harmonization, Table of Contents, RPS ToC

Brazilian Regulators Propose Amendments to Country's Clinical Trial Rules By Louise Zornoza, RegLink News - Published 08 August 2014

Brazil’s national regulatory agency, Anvisa, announced on 4 August 2014 that it has opened consultations on two separate proposed regulations that would amend existing procedures governing clinical trials with both drugs and medical devices.

Categories: News, Latin America and Caribbean, Anvisa, IMDRF, Clinical, Drugs, Medical Devices

Tags: Brazil, Clinical Trial Regulations, IMDRF