Possible Recommendation against 医機連、AMDD、EBC

医機連、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%E6%A9%9F%E9%80%A3%E3%80%81AMDD%E3%80%81EBC&limit=10

Action summary

Company
医機連、AMDD、EBCJapanese original
Original: 医機連、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

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、臨床研究の活性化、デバイスロスの改善、広告規制の見直し、越境ECの規制強化、環境規制への対応、輸出手続きの効率化、業態とQMS制度の見直しなど。

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
2026-05-04T12:02:35.069+00:00
Evidence checked
2026-05-04T12:02:35.069+00:00
Archive captured
2026-05-04T12:02:35.894+00:00
Show audit JSON
{
  "record": {
    "id": "959a48dc-5f9e-46f0-8538-f80d2982e9dd",
    "url": "https://regbase.jp/en/enforcement/yakkiho-yi-ji-lianamddebc-unknown",
    "company_name_original": "医機連、AMDD、EBC",
    "company_name_registry": "医機連、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-ji-lianamddebc-unknown",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_65484.html",
    "archiveUrl": "https://kiroku.today/view/8869646b79r5gtgk",
    "archiveCapturedAt": "2026-05-04T12:02:35.894+00:00",
    "extractedAt": "2026-05-04T12:02:35.069+00:00",
    "translatedAt": null,
    "evidenceCheckedAt": "2026-05-04T12:02:35.069+00:00",
    "generatedAt": "2026-06-19T09:10:22.723Z"
  },
  "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.

Company info

English name
医機連、AMDD、EBC Japanese original
Japanese name
医機連、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.