Onsa Advisors S.A. (ONSA) has a local Chinese team composed of people who have been working for many years with Swiss customers.They all know the Swiss quality standards and Swiss expectations. ONSAs local team has sourced reliable Chinese producers of medical material whose certification has been carefully reviewed.CE Marking When Importing From ChinaA Complete GuideSuggestionWatch the 10 minutes video tutorial before reading this article. CE Marking Course For ImportersClick Here. Importing products from China to the European Union? Depending on the product, importers are required to ensure full compliance with all relevant CE directives a process that is far more complex than requesting a test report from your supplier.Guide on medical devices (MD/IVD) CE marking (mark AttentionAccording to Directive 2007/47/EC which, will become mandatory on 21 March 2010, has amended the Directive 93/42/EEC, Medical Device meansany instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary
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A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. Manufacturers can choose any notified body for conformity assessment (audit European Standards CENA European Standard is a standard that has been adopted by one of the three recognized European Standardization Organizations (ESOs)CEN, CENELEC or ETSI. It is produced by all interested parties through a transparent, open and consensus based process. European Standards are a key component of the Single European Market.Orthofix wins FDA, CE Mark for next gen MassDeviceMar 07, 2018 · Orthofix (NSDQ:OFIX) said today it won FDA approval in the US and CE Mark approval in the European Union for its next gen PhysioStim bone growth stimulator devices. The
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