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medical device

AdvaMed, MDMA Pursue Different Approaches to Pending Medical Device Excise Tax

The medical device excise tax provision passed last year as part of the Patient Protection and Affordable Care Act in the US has drawn heavy fire from industry groups, with entities such as the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) pushing for either clarification of how the rule will be implemented and enforced or for outright repeal of the tax. Set to go into effect in 2013, the rule in question would levy a 2.3% tax on all medical device manufacturers' US sales revenues.

Eucomed: Ease Regulatory Requirements for Smaller-tier Medical Device Makers

European medical device industry trade group Eucomed has issued four major recommendations to the European Commission regarding easing regulatory requirements for small and medium-sized enterprises (SMEs) in order to foster innovation. Eucomed has published a position paper, European Health and SMEs: Big Challenges, Small & Medium Sized Solutions, following a survey the group conducted over the course of 2010 of 12 European national medical technology industry associations to pinpoint major regulatory barriers to SMEs.

AdvaMed-sponsored Study: FDA Less Efficient than EU Regulators

A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.

Survey: Prosperous Year Ahead for Medical Device Industry

Prospects look healthy for the global medical device industry according to results of the 2011 Medical Device Industry Outlook, a survey of more than 1,800 industry participants conducted by Emergo Group in collaboration with Medical Device Summit. Survey respondents indicated optimistic expectations both for themselves and for the industry as a whole, driven primarily by international business opportunities. Among the survey's key findings: