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Press releases from the Journal of Medical Device Regulation and Global Regulatory Press

The Journal of Medical Device Regulation has a new look (14 January 2014)

With publication of the upcoming February 2014 edition, the Journal of Medical Device Regulation will have a new look. While the contents will remain the same – covering important changes and news in the international medical device regulatory arena – the updated presentation will emphasise the global nature of the quarterly publication. In particular, the News Section is being re-structured to reflect the categories of: Europe - North America - Central & South America - Asia, Africa & the Middle East - Global Interest. More >>

Leading healthcare communications expert Mario R Nacinovich joins Editorial Advisory Board of Journal of Medical Device Regulation (15 May 2012)

The Editor of the Journal of Medical Device Regulation, Victoria Clark, announced today the appointment of Mario R Nacinovich to the Journal’s Editorial Advisory Board. Mario is Managing Partner for AXON, Editor-in-Chief of the Journal of Communication in Healthcare and a member of the adjunct faculty at Boston University. More >>

Introducing the fundamentals of European medical device regulations – the Journal of Medical Device Regulation publishes an update of A Beginners' Guide to the European Medical Devices Directive (MDD) (21 November 2011)

Newcomers to the field of medical device regulation in Europe have a new guide to steer them through the maze of obligations and requirements. The Journal of Medical Device Regulation has released an update of its best-selling publication entitled A Beginners' Guide to the European Medical Devices Directive (MDD). More >>

A Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe (28 April 2011)

No regulations on the own-brand labelling of medical devices exist in the European Union, which is the essence of the problem elucidated in an article published in the May 2011 issue of the Journal of Medical Device Regulation (JMDR). The article is entitled ‘A Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe’ and is written by Haroon Atchia, a member of the JMDR’s Editorial Advisory Board and CEO of Quality First International, London, UK. More >>

New emerging medical device market and its regulations: South Korea (10 August 2010)

The Journal of Medical Device Regulation (JMDR) has published a new, 8-page publication entitled, Medical Device Regulatory Requirements in South Korea. South Korea is emerging as a prominent medical device market. With a growing gross domestic product, and rising per capita healthcare expenditure, its medical device market can be lucrative for foreign manufacturers. In fact, imports account for the vast majority of the total market. Once the strategy of how to navigate the Korean Food and Drug Administration regulatory scheme has been established, South Korea’s medical device market emerges even more attractive, particularly so for foreign manufacturers. Fortunately, these trends are only forecast to increase. More >>

Expanding the understanding of the classification system described by the European Medical Devices Directive: New guidance document published (6 October 2009)

Global Regulatory Press has published a guidance document entitled 'Principles and Practice of Medical Device Classification'. The guidance document presents an introduction to the principles and practice of classification of medical devices. It expands education on the classification system described by the European Medical Devices Directive, introducing the reader to the fundamentals of classification, in an attempt to explore the origin, design, construction and practice of the scheme according to the theory and practice of classification. More >>

EMEA to Play a Bigger Role in Regulatory Development Processes (8 July 2008)

In its upcoming August 2008 issue, the Journal of Medical Device Regulation (JMDR) will publish an article entitled "Future Revision of the European Medical Devices Directives" by Dr David Jefferys. In May 2008, the European Commission launched a public consultation on its proposals for recasting (in a Regulation) Directive 90/385/EEC (on implantable medical devices), Directive 93/42/EEC (general framework) and Directives 2000/70/EC and 2001/104/EC (on blood derivatives). Dr Jefferys examines the details of this questionnaire, which he believes clearly reveals the current thinking within the Commission and suggests a high involvement of the European Medicines Agency (EMEA) in future regulatory developments. More >>

Publication of Revisions to the European Medical Device Directive Expected by End of 2007 (30 August 2007)

The amendments to the European Medical Device Directive (MDD) are expected to be published in the Official Journal towards the end of 2007 once the legal and linguistic review has been completed and the final text has been adopted. It is vital for companies to know exactly how the MDD has been amended and to understand how to meet its revised requirements. However, an updated version of the Directive itself is not expected to be published so companies will have to cross-refer to several documents to identify what changes have taken place. To simplify the process, the Journal of Medical Device Regulation has published a supplement entitled Key Revisions to the European Medical Device Directive, 93/42/EEC. More >>

JMDR Editorial Advisory Board Members to Speak at Upcoming Regulatory Events (23 August 2007)

Several Editorial Advisory Board members of the Journal of Medical Device Regulation (JMDR) are to attend important regulatory conferences throughout the second half of 2007. Meetings with Board members at these events can be arranged through Marija Capek, PR and Press. More >>

Datuk Dr Mukundan Sugunan Pillay from Ministry of Health, Malaysia, joins Editorial Advisory Board of Journal of Medical Device Regulation (18 July 2007)

The Journal of Medical Device Regulation (JMDR), the international reference source in regulatory affairs for medical devices, announces that Datuk Dr Mukundan Sugunan Pillay, Deputy Director General of Health, Research and Technical Support at the Ministry of Health in Malaysia, has joined its Editorial Advisory Board. The announcement was made today by Victoria Clark, Editor of the quarterly publication, which reaches regulatory professionals in the US, Canada, the Middle East, Asia and Europe. More >>

Cordis RA expert Elena Jugo joins Editorial Advisory Board of Journal of Medical Device Regulation (5 February 2007)

The Editorial Advisory Board of the Journal of Medical Device Regulation (JMDR) announced today the appointment of Elena Jugo from Cordis Corporation. With 20 years' experience in the clinical research, regulatory affairs and quality assurance fields, Elena Jugo currently holds the position of Manager of Regulatory Affairs in Cordis Corporation. More >>

'Medical Device Law Award 2006' presented to JMDR Editorial Advisory Board member Rainer Hill (2 November 2006)

Rainer Hill, a member of the Editorial Advisory Board of the Journal of Medical Device Regulation (JMDR) and Deputy Director General of BVMed, Berlin, has received the Medical Device Law Award 2006, which is an honorary prize presented annually by the German publishing house pmi Verlag AG. The award ceremony took place on the occasion of the 'German Day of Medical Device Regulation' in Frankfurt/Main, Germany. More >>

How far can the validity of 'piggy-backed' products be stretched? (28 September 2006)

In the upcoming November 2006 issue, the Journal of Medical Device Regulation (JMDR) will publish an article written by David R Pickard from the UK consultancy Quality First International entitled Ethylene oxide sterilisation validation - How far can the validity of 'piggy-backed' products be stretched? The article examines many crucial issues of so-called piggy-back medical devices, an increasingly-used term in the medical device industry when referring to the addition of similar products, totally different products, or the same products but in different primary packaging, to the scope of an existing ethylene oxide (EtO) sterilisation validation study. More >>

Jorge Garcia from JMDR Editorial Advisory Board to attend 10th Global Harmonisation Task Force Conference (15 June 2006)

Jorge Garcia, member of the Editorial Advisory Board of the Journal of Medical Device Regulation (JMDR), will attend the 10th Global Harmonisation Task Force (GHTF) Conference in Luebeck, Germany from 28-30 June. Dr Garcia is the chair of GHTF's Study Group 2 and will contribute two presentations at the three-day conference. On Wednesday 28 June 2006, he will participate in the workshop on "Post-production surveillance – available tools and latest developments"; on Friday 30 June 2006 he will make a presentation on vigilance-related issues. Dr Garcia joined the JMDR's Editorial Advisory Board in 2004. More >>

Dr Sergio J Gadaleta Joins Editorial Advisory Board of Journal of Medical Device Regulation (13 December 2005)

Sergio J Gadaleta PhD, former FDA insider, current Director of a multi-national regulatory department in a $3 billion medical device manufacturer, and one of America's leading authorities on US and EU regulations for a variety of medical device and combination products, has been appointed to the Editorial Advisory Board of the Journal of Medical Device Regulation. The announcement was made today by Victoria Clark, Editor of the quarterly publication, which reaches regulatory professionals in the US, Canada, the Middle East, Asia and Europe. More >>

International RA expert David Jefferys joins Editorial Advisory Board of Journal of Medical Device Regulation (6 December 2005)

With the appointment of Dr David Jefferys, one of the medical devices industry's most influential and renowned RA specialists joins the Editorial Advisory Board of the Journal of Medical Device Regulation. Dr Jefferys is a high-profile guest speaker at industry conferences where he contributes expert statements on current RA issues. He has also made his mark as an opinion leader by participating in various activities for international projects and organisations in the medical devices field. More >>

Vigilance is Not Enough (4 August 2005)

Design for patient safety is a central issue for the current UK health Presidency of the EU. The Journal of Medical Device Regulation has published an article written by Dr David Jefferys entitled "Beyond Medical Device Vigilance", which addresses some of the most crucial issues of current medical device vigilance systems. More >>

Launch of the Journal of Medical Device Regulation (8 February 2005)

Editor Victoria Clark announces the launch of a new medical device regulatory journal, the Journal of Medical Device Regulation. The Journal is published by Global Regulatory Press, London, UK, and features an all-professional editorial board with members from medical device authorities, industries and academic institutions. More >>