iia – -Translation – Keybot Dictionary

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Keybot 2 Results  www.arva-equipment.com
  United Arab Emirates  
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All manufacturers of Class I, Class IIa, Class IIb, Class III and Active Implantable Devices have to be registered with the UAE Ministry of Health.
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TÜV SÜD具備資深經驗和專業實力，能夠協助製造商獲得符合阿聯酋要求的必要驗證許可。另外， TÜV SÜD還可協助製造商獲得自願認可標籤。
  European Union Medical ...  
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Systematic clinical evaluation of Class IIa and Class IIb medical devices - Manufacturer will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
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在立法規程的該階段，MDR還將出現其他變化，在歐盟官方公告當中公佈MDR以前，擬定規範的實際條款並非最終條款。但是，多數類型醫療器材的複雜開發流程與制定全新管制要求，以及獲得公告機構審核等需求相結合，因此，過渡過程可能會極其複雜，並且十分耗時。另外，當前獲得審核通過的醫療器材還需滿足全新規範要求，並且需要接受進一步評估和審核。