Enforcement record

Recommendation 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 disclosure27 August 2021

Action type

Recommendation

Law

不明

Authority

Ministry of Health, Labour and Welfare

Action date

27 August 2021

Current page: Enforcement record

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

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Preserved evidence by Kiroku

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For developers: JSON integration details

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/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

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
Recommendation
勧告
Action date
27 August 2021
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省
Industry context
医療機器・IVD

Violation

Machine-translated summary — verify against original

Explanation of efforts related to international harmonization, reference country designation, challenges and requests for programmable medical devices, work style reform, and utilization of IT systems.

Show original Japanese text

国際整合、リファレンスカントリー化、プログラム医療機器の課題と要望、働き方改革とITシステム活用に関する取組を説明。

Compliance context

Medium

A regulator issued a recommendation or formal request for corrective action.

Japanese regulatory disclosure under 不明.

Review the facts and follow-up status. This is usually less severe than a suspension or revocation, but still a public enforcement signal.

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
2026-04-27T12:01:22.889+00:00
Evidence checked
2026-04-27T12:01:22.889+00:00
Archive captured
2026-04-27T12:01:51.630761+00:00
Show audit JSON
{
  "record": {
    "id": "9964391f-9201-4a65-8132-d1dde93c064c",
    "url": "https://regbase.jp/en/enforcement/other-mi-guo-yi-liao-ji-qi-ivdgong-ye-hui-20210827",
    "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": "勧告",
      "en": "Recommendation"
    },
    "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": "Medium",
    "actionMeaning": "A regulator issued a recommendation or formal request for corrective action.",
    "practicalNote": "Review the facts and follow-up status. This is usually less severe than a suspension or revocation, but still a public enforcement signal.",
    "lawContext": "Japanese regulatory disclosure under 不明."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-mi-guo-yi-liao-ji-qi-ivdgong-ye-hui-20210827",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21919.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/2077ea6711h5c82q",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21919.html",
    "archiveCapturedAt": "2026-04-27T12:01:51.630761+00:00",
    "extractedAt": "2026-04-27T12:01:22.889+00:00",
    "translatedAt": "2026-05-01T09:43:06.897+00:00",
    "evidenceCheckedAt": "2026-04-27T12:01:22.889+00:00",
    "generatedAt": "2026-08-04T17:34:10.934Z"
  },
  "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.

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