Recommendation against 日本臨床検査薬協会

日本臨床検査薬協会 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareConfirmed entity match

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/api/v1/enforcements?corporate_number=4010005018578&limit=10

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Action summary

Company: 日本臨床検査薬協会Japanese original
Original: 日本臨床検査薬協会
Corporate Number: 4010005018578
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: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: Recommendation
勧告
Action date: Unknown
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Review of the classification of in vitro diagnostics, international harmonization of regulations, digitization of package inserts, revision of administrator qualification requirements, optimization of regulation and review, standardization of in vitro diagnostics, and explanation of the history and current status of regulations.

Show original Japanese text

体外診のクラス分類の見直し、規制の国際整合、添付文書の電子化、管理者資格要件の見直し、規制と審査の最適化、体外診の自主基準化、規制の歴史と現状の説明。

Compliance context

Medium

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

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

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 announcement (Japanese)Archived source snapshot

Extracted at: 2026-04-27T12:01:53.108+00:00
Evidence checked: 2026-04-27T12:01:53.108+00:00
Archive captured: 2026-04-27T12:01:53.57+00:00

Show audit JSON

{
  "record": {
    "id": "9610da04-627f-4a68-9071-5ab03891ed31",
    "url": "https://regbase.jp/en/enforcement/yakkiho-ri-ben-lin-chuang-jian-cha-yao-xie-hui-unknown",
    "company_name_original": "日本臨床検査薬協会",
    "company_name_registry": "日本臨床検査薬協会",
    "corporate_number": "4010005018578",
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "勧告",
      "en": "Recommendation"
    },
    "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": "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": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-ri-ben-lin-chuang-jian-cha-yao-xie-hui-unknown",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_65484.html",
    "archiveUrl": "https://kiroku.today/view/8869646b79h5cx6x",
    "archiveCapturedAt": "2026-04-27T12:01:53.57+00:00",
    "extractedAt": "2026-04-27T12:01:53.108+00:00",
    "translatedAt": "2026-05-01T09:43:12.017+00:00",
    "evidenceCheckedAt": "2026-04-27T12:01:53.108+00:00",
    "generatedAt": "2026-06-19T08:23:21.528Z"
  },
  "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)

Company info

English name: 日本臨床検査薬協会 Japanese original
Japanese name: 日本臨床検査薬協会
Corporate Number: 4010005018578
Registered address: 東京都中央区東日本橋２丁目２４番１４号

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.