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Italian Device Registration : ウィキペディア英語版
Italian Device Registration
The Italian Ministry of Health (MOH) has implemented mandatory procedures for the Italian registration of medical devices as of 1 May 2007.
== Overview ==

Placing a Medical Device into the European market is contingent upon compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law to all 27 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating local legislation.
An example of such local implementation of the Directive is now present in Italy. Italy requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process. This process is similar to the pre-market notification requirement for Class I Medical Devices (as stated in the European Directive MDD 93/42/EEC Article 14); however, in Italy it is applicable for all classes, not only Class I.
Local legislations, such as this one, are growing rapidly in Europe and strengthen the need for a professional European Authorized Representative present at all times.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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