Administrative Guidance against Yi Liao Ji Qi Meka
Action summary
- Company
- Yi Liao Ji Qi MekaRomanizedOriginal: 医療機器メーカー
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Administrative Guidance行政指導
- Action date
- Unknown
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
In 2019, the Pharmaceuticals and Medical Devices Act was amended to establish a system considering the characteristics of medical devices such as IDATEN, and its enforcement has commenced. Such systems need to adapt to the rapidly evolving medical technologies, medical devices, in vitro diagnostic reagents, and software medical devices.
Show original Japanese text
令和元年に薬機法が改正されて、いわゆるIDATENなどの医療機器の特性を踏まえた制度ができ、その施行もされております。こうした制度というものは、日々、日進月歩で変わる医療技術、医療機器・体外診断薬、あるいはプログラム医療機器などに対応したものとする必要があります。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.