EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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emdt.co.uk European Medical Device Technology Spring 2014 | 35 would not avoid market access for foreign medical technology and new staff could be properly trained and appointed without time pressure. A possible medium-term solution would be the establishment of a third-party inspection to monitor those Brazilian GMP requirements that are not covered by ISO 13485. As a first step to build the necessary trust and confidence in the third-party monitoring capabilities, SPECTARIS proposes joint audits, where representatives from European and Brazil- ian Notified Bodies join forces to guar- antee effective and reliable examination procedures. The idea is not entirely new: Agreements for third-party inspections have occurred between some European Notified Bodies and FDA, as well as with Taiwan and Japan. Finally, the most constructive long-term solution would be a single audit program between Brazil and the European Union. UÊ " i -Ì « - «« } UÊ À>`Ê}iiÀ}Ê «iÌiVi Ê Ê 7iÊÕ`iÀÃÌ>`ÊÌiÊii`ÃÊvÊÕÀÊVÕÃÌiÀÃÊvÀÊV«iÝÊ>`Ê}«ÀiVÃÊ«>ÃÌVÊV«iÌðÊ"ÕÀÊ>`Û>Vi`Ê«ÀViÃÃ}ÊÌiV µÕiÃÊÊÕÌV«iÌÊ`}]Ê,ÊÛiÀ`}Ê>ÃÊÜiÊ>ÃÊVÀ`}Ê>ÜÊÌiÊVÀi>ÌÊvÊ`ëÃ>LiÊ`>}ÃÌVÊÃÞÃÌià >`Êi`V>ÊiÛViÃÊÜÌÊ>Ê«ÀiÛÕÃÞÊÕ>ÌÌ>>LiÊV«iÝÌÞ°Ê «iÌiÊÕÃiÊV>«>LÌiÃÊvÀÊ«>ÀÌÊ`iÃ}ÊÌÊ>Õv>VÌÕÀ}Ê >`Ê«>V>}}Ê>iÊ7 ÊÞÕÀÊÌÕÀiÞÊ«>ÀÌiÀ°Ê/`>Þ°Ê/ÀÀÜ°Ê`ÊvÀÊÞi>ÀÃÊÌÊVi°ÊÊÊÊ Visit us at Medtec, Stuttgart, Germany, 3 – 5 June 2014, Booth 5 F 20 Competitive advantage through precision, speed and uniqueness UÊ iÃ}ÊÌÊ ÃÌÊ UÊ ,Ê>`Ê>L «Ê-ÞÃÌià WEIDMANN PLASTICS TECHNOLOGY AG, Medical Division, Switzerland and USA, www.weidmann-plastics.com UÊ i>Ê,ÃÊ >ÃÃiÃÊÇÊ> `Ên® UÊ Õ ÞÊÕÌ>Ìi`ÊÃÃiL ÞÊ Ê A Member of the WICOR Group © Swiss Airforce This solution is particularly attractive in light of the Memorandum of Understand- ing that was signed by U.S., Canadian and Australian Notified Bodies with their Bra- zilian counterparts in 2012, which may put European companies at a considerable disadvantage. Regardless of the approach, accelerating market entry for foreign medical tech- nology and addressing major barriers is critical to the future of the market. Doing so means quicker and easier access to life- saving innovation and, in turn, access to the better standard of care demanded by the Brazilian people. Snapshot of Brazil's Medical Device Market ■ The Brazilian medical device mar- ket was valued at US$5,918.9 million in 2013. ■ More than 75% of medical device imports came from the United States and Europe in 2012. ■ The highest medical expenditure is in major cities, but producers are expanding into regional markets. ■ The expansion of private health insurance has prompted increased expenditures in medical equipment. ■ BRL2.3bn (US$1.1 billion) was slated for investment in the develop- ment of primary health and emer- gency care services in 2013. Source: "The Medical Device Market: Brazil," published by Espicom, January 2014. Stephanie von Meien Senior Manager, Germany Trade and Invest, Friedrichstraße 60, 10117 Berlin, Germany Tel: +49 30 200 099-755 info@health-made-in-germany.com www.gtai.com ES430866_EMDT1405_035.pgs 04.29.2014 03:32 UBM black yellow magenta cyan

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