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

RegBase evidence report

Japanese public-record enforcement check

Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.

Report ID: RB-EN-ENFORCEMENT-OTHER-MI-GUO-YI-L-202608041531
Generated at: 5 August 2026 at 00:31
Record URL: https://regbase.jp/en/enforcement/other-mi-guo-yi-liao-ji-qi-ivdgong-ye-hui-20241007

1. Review Summary

Disclosure name	米国医療機器・IVD工業会	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	7 October 2024	Authority	Ministry of Health, Labour and Welfare
Law	不明	Action type	要望
Source status	Preserved public-source archive recorded

This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.

2. Published Information

Published name	米国医療機器・IVD工業会

3. Enforcement Record

Target name in disclosure	米国医療機器・IVD工業会
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	不明 / 要望
Action / announcement date	Action: 7 October 2024 / Announcement: 20 April 2026
English summary	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%.
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。
Official source	https://www.mhlw.go.jp/stf/newpage_45374.html
Source archive	https://kiroku.today/a/13e38ef46adenrux
Extraction / evidence timestamps	Extracted: 25 April 2026 at 09:26 / Evidence checked: 25 April 2026 at 09:26 / Archive captured: 14 June 2026 at 15:33

4. Business Location and Permit Details

No additional structured business-location or permit fields are recorded for this disclosure.

5. Other Confirmed Records for This Company

This report covers the single government disclosure shown on this page.

Reviewer Notes

Reviewer		Team / company
Review purpose
Additional notes

□ Official source URL or archived source was checked.
□ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
□ This document is understood as a public-record evidence file, not a credit decision or legal opinion.

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Free report

Save the disclosure record naming 米国医療機器・IVD工業会

Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.

Preserved evidence by Kiroku

Review the preserved source for 米国医療機器・IVD工業会

Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.

Open preserved source and evidence pack

For developers: JSON integration details

You do not need this for normal browsing. Use it only when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?company=%E7%B1%B3%E5%9B%BD%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%83%BBIVD%E5%B7%A5%E6%A5%AD%E4%BC%9A&limit=10

Open JSON Specs

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.

Evidence pack

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": "2026-08-04T15:31:16.037Z"
  },
  "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.