Possible Recommendation against 医療機器産業連合会、AMDD、EBC

医療機器産業連合会、AMDD、EBC (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 match

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/api/v1/enforcements?company=%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E7%94%A3%E6%A5%AD%E9%80%A3%E5%90%88%E4%BC%9A%E3%80%81AMDD%E3%80%81EBC&limit=10

Open API response API docs

Action summary

Company: 医療機器産業連合会、AMDD、EBCJapanese original
Original: 医療機器産業連合会、AMDD、EBC
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: Unknown
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Construction of a medical device database, mandatory registration of UDI information, promotion of medical data utilization, regulatory harmonization of clinical trials and research, investigation and improvement of device loss, development of guidelines for medical advertising, strengthening of regulations on cross-border e-commerce, response to environmental regulations, international harmonization of QMS surveys, review of business practices, and revision of management qualification requirements.

Show original Japanese text

医療機器データベースの構築、UDI情報登録義務、医療データの利活用促進、臨床試験・研究の規制調和、デバイスロスの調査と改善、医療広告のガイドライン整備、越境ECの規制強化、環境規制への対応、QMS調査の国際整合、業態見直し、管理者資格要件の見直しなど。

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: 2026-04-27T12:01:51.544+00:00
Evidence checked: 2026-04-27T12:01:51.544+00:00
Archive captured: 2026-04-27T12:01:52.303+00:00

Show audit JSON

{
  "record": {
    "id": "65f74e08-58ff-4c08-bd3c-5968162e1fbd",
    "url": "https://regbase.jp/en/enforcement/yakkiho-yi-liao-ji-qi-chan-ye-lian-he-huiamddebc-unknown",
    "company_name_original": "医療機器産業連合会、AMDD、EBC",
    "company_name_registry": "医療機器産業連合会、AMDD、EBC",
    "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-yi-liao-ji-qi-chan-ye-lian-he-huiamddebc-unknown",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_65484.html",
    "archiveUrl": "https://kiroku.today/view/8869646b79h5cx6x",
    "archiveCapturedAt": "2026-04-27T12:01:52.303+00:00",
    "extractedAt": "2026-04-27T12:01:51.544+00:00",
    "translatedAt": "2026-05-01T09:43:10.277+00:00",
    "evidenceCheckedAt": "2026-04-27T12:01:51.544+00:00",
    "generatedAt": "2026-06-19T08:23:18.818Z"
  },
  "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: 医療機器産業連合会、AMDD、EBC Japanese original
Japanese name: 医療機器産業連合会、AMDD、EBC

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.