| February 8, 2013 | News for medical technology professionals |
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 | Exporting to Europe: Medical Device Requirements
Join BSI to gain a basic understanding of the CE Marking regulatory process and the impact the Medical Device Directive (MDD) requirements have on marketing a new medical device in the EU. Learn the different medical device risk classifications and when you need a Notified Body.
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| International Developments |  |  |
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- China expects significant growth in medical device market
Increasing demand for upgraded medical devices in China will help expand the market, which is expected to surpass Japan as the second largest medtech market in the world within the next seven years and account for a quarter of the world market by 2050, according to consulting firm PharmaLive. Currently, 60% of medical devices in China's health institutions were installed prior to the mid-1980s. Xinhuanet.com (China)
(2/5)      
- Assobiomedica: Italy to cut medtech spending by 33% through 2014
Italy's austerity measures could reduce medical technology spending in the country by about €4.2 billion, or 33%, between 2013 and 2014, according to Assobiomedica. The industry association's figure is significantly more than the government's €3 billion estimate and is based on a study by its Centro Studi (CSA) research group. Clinica
(2/4)
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- Senate bill takes aim at 2.3% medical device tax
A bipartisan bill that would repeal the 2.3% medical device tax has been introduced in the Senate. Industry leaders and lawmakers in favor of the repeal said the tax will threaten job growth and medical innovation. "In order to compete in the global economy our medical device businesses need a level playing field," said Sen. Amy Klobuchar, D-Minn. Reuters
(2/7)
- Sequester could slow or stop FDA reviews, analyst warns
FDA operations will be limited by budget sequestration if lawmakers don't move to stop an 8.2% automatic cut before March 1, the consulting firm Avalere Health warned. "An underfunded FDA could lead to FDA review clocks being reset or delayed, which would affect a sponsor's ability to obtain product approval -- thus delaying patient access to cutting edge medical innovations," Avalere said in its report. The Hill/Healthwatch blog
(2/5)
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