Enforcement record
要望 disclosure naming 米国医療機器・IVD工業会
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
要望
Law
不明
Authority
Ministry of Health, Labour and Welfare
Action date
7 October 2024
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Source verification
Public-source and preservation status
- Publishing authority
- Ministry of Health, Labour and Welfare
- Official source URL
- Recorded by RegBase
- Entity match
- Not confirmed; shown under the published name
- Kiroku preservation
- Queued for preservation
- Captured: Jun 14, 2026, 03:33 PM JST
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Public documents and saved materials
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Action summary
- Company
- 米国医療機器・IVD工業会Japanese onlyOriginal: 米国医療機器・IVD工業会
- Governing law
- 不明不明
- Action type
- 要望要望
- Action date
- 7 October 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。
Compliance context
Context neededThis is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.
Japanese regulatory disclosure under 不明.
Review the original Japanese source and determine relevance to your counterparty-risk workflow.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
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.