
Overview of INMETRO Certification for Medical Devices White Paper (JP)
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ブラジルで販売されるすべての医療機器は、Agência Nacional de Vigilância Sanitária(ANVISA:ブラジル国家衛生監督庁)に登録する必要があります。ANVISAは、全ての医療機器の登録と審査業務を管轄する機関です。
ANVISAによる規則「Resolução da Diretoria Colegiada RDC no. 549:2021」は、現地市場に参入する製品をANVISAに登録するための前提条件となる、電気医療機器に対するINMETRO(ブラジル国家度量衡・規格・工業品質院)の認証取得を義務付ける制度の方針を定め、制度を制定しています。
またこの規則には、各機器が適合しなければならない規格と実施日を規定する「Instrução Normativa」の仕組みについても記載されています。
本資料では、UL Solutionsの下でINMETRO認証を取得・維持するために必要な省令 384/2020号の要件を詳しく説明しています。
Overview of INMETRO Certification for Medical Devices White Paper (JP)