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Regulatory Region - Europe
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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 . ...
INTERVIEW
Notified body TÜV PS calls for competent authority action in Europe
23 July 2010
Amanda Maxwell
TÜV Product Service , one the main notified bodies for medical devices in the European Union, is in no doubt that the basic EU medtech regulatory ...
LATEST FEATURES
EMA seeks out ATMP manufacturers in advance of approval deadlines
18 February 2011
Maureen Kenny reports on efforts by the European Medicines Agency to ensure manufacturers of advanced therapies won't be caught out by approaching ...
The revision of the EU medical device directives revision and variations in national laws
12 January 2011
How successful have the EU member states been in implementing the revision of the medical device directives into national law? And has this been done ...
Approaching Rules in Russia Signal Stronger Focus on Devices(Test)
16 November 2010
Daria Pozharova considers the difficulties involved in registering medical devices in Russia and discusses developments that promise to improve the ...
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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 ...
>> More Latest Country Profiles...
MULTIMEDIA
RAJ Devices News Roundup, 11 December 2009
28 July 2011
PEOPLE
Pharmacist takes the helm of Spanish regulator
Belén Crespo Sánchez-Eznarriaga has been appointed director of the Spanish healthcare products regulatory agency, the AEMPS (Agencia Española de ...
>> More People News...
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EVENTS
Overview of ISO 13485:2003, the CMDRs, the MDD, and JPAL
21September 2009
Minneapolis (MN), US
