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Regulatory Region - International
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EXPERT VIEW
In praise of the CE marking, but medtech's worst fear is still alive
06 July 2010
Ashley Yeo
The European Medicines Agency review meeting in London on 30 June passed with scarcely a mention of devices and diagnostics. This was perhaps as expected, given that the meeting, held to examine the outcomes of the assessment of Ernst & Young's ...
LATEST FEATURES
In Vitro Diagnostics - Global Supply Chains, Global Regulatory Challenges
22 June 2010
Sharon Williams discusses the regulatory hurdles for IVDs. The in vitro diagnostics industry represents one of the most lucrative segments in the ...
Compliance, Compliance, Compliance
14 May 2010
Participants at the 2010 International Medical Device Industry Compliance Conference examined this hot issue from all angles, reports Karen Finn . ...
Medical Device Counterfeiting - Still Very Much an Unknown
01 February 2010
Medical device counterfeiting clearly exists. Adrie de Bruijn , Claudette de Vries and Harm Hermsen report that while around the world authorities ...
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LATEST COUNTRY PROFILES
Trademarks Briefing (Devices) - Luxembourg
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
Regulation of Medical Devices Briefing - Spain
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia Española del Medicamento, the ...
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MULTIMEDIA
RAJ Devices News Roundup, July 2010
19 July 2010
PEOPLE
Appointments May-June 2009
Kathleen Sebelius has been sworn in as secretary of the US Department of Health and Human Services . Ms Sebelius was previously governor of the state ...
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