要望 against 米国医療機器・IVD工業会

米国医療機器・IVD工業会 (不明)
不明Ministry of Health, Labour and WelfareConfirmed entity match7 October 2024
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/api/v1/enforcements?corporate_number=2011205002084&limit=10

Action summary

Company
Original: 米国医療機器・IVD工業会
Corporate Number: 2011205002084
Entity match
Confirmed entity match95/100Machine extracted
Normalized Japanese name matched to a company profile with Corporate Number
Matched by normalized Japanese company name to an enriched company profile with a Corporate Number.
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

Machine-translated summary — verify against original

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 needed

This 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.

Evidence pack

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot
Extracted at
2026-04-25T00:26:28.309+00:00
Evidence checked
2026-04-25T00:26:28.309+00:00
Archive captured
2026-06-14T06:30:35.025+00:00
Show audit JSON
{
  "record": {
    "id": "b068d1d7-f1f3-4d88-b25e-736ca8fd563c",
    "url": "https://regbase.jp/en/enforcement/other-mi-guo-yi-liao-ji-qi-ivdgong-ye-hui-20241007",
    "company_name_original": "米国医療機器・IVD工業会",
    "company_name_registry": "米国医療機器・IVD工業会",
    "corporate_number": "2011205002084",
    "law": {
      "ja": "不明",
      "en": "不明"
    },
    "action_type": {
      "ja": "要望",
      "en": "要望"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "confirmed",
    "confidence": 95,
    "method": "normalized_name_with_corporate_number",
    "method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
    "notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under 不明."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-mi-guo-yi-liao-ji-qi-ivdgong-ye-hui-20241007",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_45374.html",
    "archiveUrl": "https://kiroku.today/view/13e38ef46adenrux",
    "archiveCapturedAt": "2026-06-14T06:30:35.025+00:00",
    "extractedAt": "2026-04-25T00:26:28.309+00:00",
    "translatedAt": "2026-05-01T07:14:25.87+00:00",
    "evidenceCheckedAt": "2026-04-25T00:26:28.309+00:00",
    "generatedAt": "2026-06-19T09:17:56.082Z"
  },
  "limitations": [
    "RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
    "English summaries are provided for reference. The original Japanese source is authoritative.",
    "Possible or unresolved entity matches should be manually verified before use in a decision."
  ]
}

The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.

Company info

English name
米国医療機器・IVD工業会 Japanese original
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
See company profile →

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.