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Premarketing Regulation - Safety
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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
ISO 14644: cleanroom classification and monitoring changes ahead
10 January 2011
Tony Harrison explains why the key revisions in the draft of international standard ISO 14644 will affect GMP-compliant companies. Parts 1 and 2 of ...
Electronic Cigarettes - Common Concerns but Not Much Regulatory Consensus
02 November 2009
Peter Charlish looks at the regulation of “e-cigarettes” and finds they can be drugs, devices, neither or both. Unless it is very tightly drawn up, ...
Change in Store for Medical Device Regulation in Germany
13 March 2009
A draft law amending Germany’s medical device regulations was finalised by the government in February and has now entered parliament, where its ...
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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
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EVENTS
Overview of ISO 13485:2003, the CMDRs, the MDD, and JPAL
21September 2009
Minneapolis (MN), US
