Basic Approach of Biological Evaluation of Medical Devices for Pre-Market Applications

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  • ANAHARA Reiko
    独立行政法人医薬品医療機器総合機構 (PMDA) 医療機器審査第二部

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  • 承認審査における生物学的安全性評価の基本的考え方
  • ショウニン シンサ ニ オケル セイブツガクテキ アンゼンセイ ヒョウカ ノ キホンテキ カンガエカタ

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Abstract

<p>The Pharmaceuticals and Medical Devices Agency (PMDA) is regulatory agency in Japan and reviews for marketing approval of pharmaceuticals and medical devices. In accordance with the Pharmaceutical Affairs Act, PMDA evaluates the efficacy, safety, and quality of drugs and medical devices for which applications have been submitted for regulatory approval, based on the current scientific and technological standards. The biological evaluation of any material or medical device intended for use in humans should part of a structured biological evaluation plan within a risk management process. When assessing new medical devices, the sponsor should evaluate the biological responses that are regarded as adverse, caused by materials in one application. This paper described how the sponsor should approach to the biological evaluation on medical devices.</p>

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