要望 against Mi Guo Yi Liao Ji Qi Ivdgong Ye Hui
Action summary
- Company
- Mi Guo Yi Liao Ji Qi Ivdgong Ye HuiRomanizedOriginal: 米国医療機器・IVD工業会Corporate Number: 2011205002084
- Governing law
- 不明不明
- Action type
- 要望要望
- Action date
- October 7, 2024
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Among the items approved by the U.S. FDA, it was found that 72% are potentially unapproved in Japan based on cross-referencing. When changing the perspective, 79% of companies without a Japanese subsidiary are potentially unapproved, whereas for companies with a Japanese subsidiary, the percentage drops to 51%.
Show original Japanese text
米国FDAにて承認された品目のうち、日本で突き合わせた結果、72％が未承認ではないかということになりました。そのうち、切り口を変えると、日本法人がない企業の場合は79％、日本法人がある場合は大分下がって51％という結果でございました。
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)Company info
- English name
- Mi Guo Yi Liao Ji Qi Ivdgong Ye Hui Romanized
- Japanese name
- 米国医療機器・IVD工業会
- Corporate Number
- 2011205002084
- Registered address
- 東京都港区東新橋１丁目５番２号汐留シティセンター５階
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.