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  • Medical Device Link .
    such as the (VDE; Offenbach, Germany), or the (Cologne, Germany). A CE marking is not legally required for components. The approval must be documented by a copy of the approval certificate or by the license for the component (the use of catalogs data sheets is not a proper way to prove compliance
  • Medical Device Link .
    such as good manufacturing practices (GMPs), allowing third-party certification instead of requiring direct MHLW approval, and developing a market authorization holder (MAH) system. Today, application forms and certification processes for IVD products differ slightly from other medical devices

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