Recommendation against 日本医療機器産業連合会

日本医療機器産業連合会 (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 match27 August 2021
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Action summary

Company
Original: 日本医療機器産業連合会
Corporate Number: 9011105006212
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
27 August 2021
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Description of proposals and exchange of opinions regarding challenges in the regulatory environment for medical devices, work style reform, promotion of digitalization, and advancement of medical device development.

Show original Japanese text

医療機器の規制環境の課題、働き方改革、デジタル化推進、医療機器の開発促進に関する提言と意見交換の実施についての記述。

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
2026-04-25T00:20:37.747+00:00
Evidence checked
2026-04-25T00:20:37.747+00:00
Archive captured
2026-04-10T00:00:49.02+00:00
Show audit JSON
{
  "record": {
    "id": "9ae0ab69-b565-4174-8eb5-d78ecece40b1",
    "url": "https://regbase.jp/en/enforcement/yakkiho-ri-ben-yi-liao-ji-qi-chan-ye-lian-he-hui-20210827",
    "company_name_original": "日本医療機器産業連合会",
    "company_name_registry": "日本医療機器産業連合会",
    "corporate_number": "9011105006212",
    "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-yi-liao-ji-qi-chan-ye-lian-he-hui-20210827",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21919.html",
    "archiveUrl": "https://kiroku.today/view/2077ea6711ijow9q",
    "archiveCapturedAt": "2026-04-10T00:00:49.02+00:00",
    "extractedAt": "2026-04-25T00:20:37.747+00:00",
    "translatedAt": "2026-05-01T07:08:53.492+00:00",
    "evidenceCheckedAt": "2026-04-25T00:20:37.747+00:00",
    "generatedAt": "2026-06-19T08:23:28.961Z"
  },
  "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
日本医療機器産業連合会 Japanese original
Japanese name
日本医療機器産業連合会
Corporate Number
9011105006212
Registered address
東京都新宿区下宮比町3番2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.