Possible Recommendation against 米国医療機器・IVD工業会（AMDD）

米国医療機器・IVD工業会（AMDD） (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 WelfarePossible entity match14 September 2023

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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%EF%BC%88AMDD%EF%BC%89&limit=10

Open API response API docs

Action summary

Company: 米国医療機器・IVD工業会（AMDD）Japanese original
Original: 米国医療機器・IVD工業会（AMDD）
Entity match: Possible entity match60/100Machine extracted
Company name extracted from the Japanese public disclosure
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: Recommendation
勧告
Action date: 14 September 2023
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Exchange of opinions on efforts toward international harmonization and reference country standardization

Show original Japanese text

国際整合とリファレンスカントリー化に向けた取組についての意見交換

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: 2026-04-25T00:26:45.691+00:00
Evidence checked: 2026-04-25T00:26:45.691+00:00
Archive captured: 2026-06-14T06:30:33.229+00:00

Show audit JSON

{
  "record": {
    "id": "5d0d965a-1c1b-4480-a461-c7e0b5b58612",
    "url": "https://regbase.jp/en/enforcement/yakkiho-mi-guo-yi-liao-ji-qi-ivdgong-ye-huiamdd-20230914",
    "company_name_original": "米国医療機器・IVD工業会（AMDD）",
    "company_name_registry": "米国医療機器・IVD工業会（AMDD）",
    "corporate_number": null,
    "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": "possible",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": null
  },
  "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-mi-guo-yi-liao-ji-qi-ivdgong-ye-huiamdd-20230914",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_35771.html",
    "archiveUrl": "https://kiroku.today/view/7547e0e12adenpzu",
    "archiveCapturedAt": "2026-06-14T06:30:33.229+00:00",
    "extractedAt": "2026-04-25T00:26:45.691+00:00",
    "translatedAt": "2026-05-01T07:14:38.465+00:00",
    "evidenceCheckedAt": "2026-04-25T00:26:45.691+00:00",
    "generatedAt": "2026-06-19T08:23:51.023Z"
  },
  "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: 米国医療機器・IVD工業会（AMDD） Japanese original
Japanese name: 米国医療機器・IVD工業会（AMDD）

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.