Search Results for Medical Device Regulations

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First Implementing Act Under EU MDR, IVDR Open for Consultation By Zachary Brennan - Published 20 October 2017

The first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices

Tags: MDR, IVDR, medical device regulations Europe

Asia Regulatory Roundup: Australia Proposes to Align Device Regulations With EU (1 August 2017) By Nick Paul Taylor - Published 01 August 2017

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

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, medical device regulations, online regulatory filing

RAPS and Industry Experts Join Forces for Dedicated MDR Workshop By RAPS Staff - Published 18 May 2017

RAPS is bringing together a panel of Europe’s top industry experts to deliver a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices.

Categories: HTML, Articles, Under RAPS, Europe, RAPS

Tags: EU, Medical Device Regulations, IVD Regulations

Final EU MDR, IVDR Texts Published, Countdown to Implementation Begins By Zachary Brennan - Published 05 May 2017

The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published on Friday in the Official Journal of the European Union, setting in motion the timeline for implementation of the new regulations, which is set to commence on 25 May.

Categories: News, Europe, US, EC, In vitro diagnostics, Medical Devices

Tags: EU MDR, IVDR, new medical device regulations, Europe regulations

EU Council Unanimously Adopts MDR, IVDR: Next Stop EU Parliament By Michael Mezher - Published 07 March 2017

The EU's new rules governing medical device and in vitro diagnostics (IVDs) are one step away from being fully adopted.

Categories: News, Europe, In vitro diagnostics, Medical Devices

Tags: Medical Device Regulations, MDR, In Vitro Diagnostics Regulations, IVDR, EU Council

Asia Regulatory Roundup: India Adopts New Medical Device Regulations (7 February 2017) By Nick Paul Taylor - Published 07 February 2017

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

Categories: News, Asia, CDSCO, CFDA, MFDS, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: India medical device regulations, DRAP, TFDA

EU Council and Parliamentary Committees Sign Off on New Medical Device, IVD Regulations By Zachary Brennan - Published 15 June 2016

The European Council's Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released.

Categories: News, Europe, EC, EMA, Clinical, Crisis management, Government affairs, Medical Devices, Quality

Tags: medical device and IVDs in EU, new device regulations, European Commission medical device regulations

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

Indian Regulators, Medical Device Associations Focus on New Guidelines, Increasing Exports By Zachary Brennan - Published 11 December 2015

India’s Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) met with medical device association representatives earlier this month to discuss how the country can become a hub for device manufacturing and begin to align with global regulations.

Categories: News, Asia, CDSCO, Clinical, Compliance, Crisis management, Distribution, Ethics, Government affairs, Medical Devices

Tags: India, medical device regulations, certificates of free sale, device exports

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

Can Some Medical Devices Skip China's Clinical Trial Mandate? By Zachary Brousseau - Published 13 February 2015

To market class II or III medical devices in China, products must undergo a registration process that also may require clinical trials, but in certain situations devices may be exempted or be allowed to undergo modified trials.

Categories: Articles, China, RAPS, Clinical, Medical Devices

Tags: China, medical device, regulations, webcast