eitarou — 翻訳実績

Regulatory Controls for Medical Devices
In mapping its regulatory framework for medical devices, HSA has adopted a measured approach to safeguard public health but without unduly restricting consumer choice and their access to new technologies. HSA has also studied the medical device regulatory systems in developed country counterparts, including the US Food and Drug Administration (FDA), European Union, Canada's Medical Devices Bureau (MDB), Japan's Ministry of Health Labour and Welfare (MHLW) and Australia's Therapeutic Goods Administration (TGA).

医療機器取締管理　　　　　　　　　　　
保険事業局は消費者の最新技術への利用選択を過度に規制することなく公衆衛生保護のための慎重な措置をとり、医療機器の規制枠組を計画した。保険事業局はまた米国食品医薬品局、ＥＵ、カナダ医療機器局、厚生労働省、オーストラリア保健省薬品・医薬品局を含む先進国における医療機器規制制度を詳細に調査した。

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