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Postmarketing Regulation - vigilance
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EXPERT VIEW
Assessing the size of the US recall issue
27 April 2011
Ashley Yeo
With the US in mid-regulatory review, stakeholders are keenly pushing for a safer and faster system, but there are different views on how these goals should be achieved. That was shown at a hearing of the US Senate's Special Committee on Aging 1 . ...
LATEST FEATURES
No More Red Tape: MHRA Awaits Tougher Sanctioning Powers in the UK
15 September 2009
The UK government in 2004 asked Philip Hampton, a leading businessman, to lead a review of regulatory inspection and enforcement across a number of ...
Medical Devices Intended for Lay Use in the EU
18 March 2009
Medical devices sold over the counter in the European Union for use by lay persons are becoming increasingly complex. High-street shops are offering ...
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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 EspaƱola del Medicamento, the ...
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MULTIMEDIA
RAJ Devices News Roundup, 11 December 2009
28 July 2011
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Overview of ISO 13485:2003, the CMDRs, the MDD, and JPAL
21September 2009
Minneapolis (MN), US