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EUROPE
06 September 2010

The UK Medicines and Healthcare products Regulatory Agency has reported that the preliminary tests it has conducted on the silicone filler used in banned breast implants made by Poly Implant Prothèse...

02 September 2010

The European Commission has issued a document clarifying certain legal obligations arising from the Customs Union Agreement that was signed between Turkey and the European Community for medical...

31 August 2010

"It is not possible to quantify the risks associated with the use of reprocessed single use medical devices". This is the thrust of the European Commission 's final report to the European Parliament...

25 August 2010

Just when it seemed it was finally on the home straight, the proposal for a single European Union patent and a unified European patent court looks like hitting another major hurdle after a leaked...

24 August 2010

Medical device wholesalers operating in Portugal have until 17 September 2010 to register with the country's regulatory authority Infarmed. This legal requirement was introduced by decree 145 of 17...

17 August 2010

The Irish Medicines Board has issued a general advisory explaining the importance of establishing and managing effective traceability systems for medical devices in all healthcare settings 1 . The...

16 August 2010

Spain has adopted a new law that strengthens its existing provisions on criminal liability and will apply to crimes such as fraud, bribery and commercial bribery 1 ,2 . The law enters into force in...

10 August 2010

The European Commission has adopted a six-point plan of action to improve the sustainability of the European Union's nuclear medicine, radiology and radiotherapy demand, with proposals also to...

10 August 2010

The UK's Academy of Medical Sciences is seeking feedback on the merits of placing responsibility for different aspects of medical research regulation, including that of clinical trials, within a...

06 August 2010

The Human Genetics Commission in the UK has issued a framework of "common principles" for direct-to-consumer genetic testing services to ensure that companies follow basic principles of consent, data...

05 August 2010

The definitive text on the European standard regarding symbols for use in the labelling of medical devices containing phthalates remains on track to be officially available on 6 December, says the...

05 August 2010

The European Medicines Agency has released for consultation guidance on how the agency's Committee for Advanced Therapies will interact with notified bodies when the committee assesses combination...

03 August 2010

Italy is to trial an electronic system for licensing medtech product advertising. The initiative promises to offer medtech suppliers a greatly simplified and faster licensing service, according to...

02 August 2010

The European Medicines Agency has released for consultation guidance on how the agency's Committee for Advanced Therapies will interact with notified bodies when the committee assesses combination...

02 August 2010

The European Commission's medical devices website has now moved to the "Consumer Affairs" web pages of DG Health and Consumers (DG SANCO) 1 . It has been transferred from DG Enterprise and Industry,...

06 August 2010
Phil Greenfield
"These two preliminary reports recommend steps to strengthen and improve the 510(k) process and the use of science in decision making" and provide a "blueprint for smarter medical device oversight". That is the understated way in which Jeffrey ...
 
30 July 2010
Amanda Maxwell
With devices becoming increasingly complex, competent authorities in the European Union must ensure there are sufficiently well-trained experts at ...
 
 
30 July 2010
With devices becoming increasingly complex, competent authorities in the European Union must ensure there are sufficiently well-trained experts at ...
23 July 2010
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 ...
09 July 2010
Eucomed's John Brennan talks to Karen Finn about Global Harmonization Task Force efforts on UDI and nomenclature, and the impact the GHTF may have on ...
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia Española del Medicamento, the ...
RAJ Devices News Roundup, August 2010
23 August 2010
 
Getinge chief exec Lindoff is new Swedish Medtech chair Swedish Medtech , the Stockholm-based national medical technology industry association, has appointed Joacim Lindoff as its chairman. Mr Lindoff, ...
UK knighthood for NICE chief executive Dillon Andrew Dillon , chief executive of the UK's National Institute for Health and Clinical Excellence , has been awarded a knighthood for services to ...
 
EVENTS
September 14th, 2010
London, UK
September 27th, 2010
London, UK
September 29th, 2010
London, UK
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