Enforcement record

要望 disclosure naming 米国医療機器・IVD工業会

米国医療機器・IVD工業会 (不明)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

不明Ministry of Health, Labour and WelfareGovernment disclosure7 October 2024

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: Completed archive verified; Captured: Jun 14, 2026, 03:33 PM JST

“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.

Open the official source links in the section below to review the original disclosure.

Action summary

Company: 米国医療機器・IVD工業会Japanese only
Original: 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

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.

Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-25T00:26:28.309+00:00
Evidence checked: 2026-04-25T00:26:28.309+00:00
Archive captured: 2026-06-14T06:33:52.791573+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": null,
    "corporate_number": null,
    "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": "unresolved",
    "confidence": 60,
    "method": "linked_profile_without_source_identifier",
    "method_label": "linked_profile_without_source_identifier",
    "notes": "The linked profile has a Corporate Number, but the public disclosure does not contain that number and no unique independent NTA name/address match was found."
  },
  "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",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/13e38ef46adenrux",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_45374.html",
    "archiveCapturedAt": "2026-06-14T06:33:52.791573+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": "2026-09-18T20:03:29.937Z"
  },
  "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.

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.