Possible Administrative Guidance against 医療機器産業連合会（医機連）
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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%EF%BC%88%E5%8C%BB%E6%A9%9F%E9%80%A3%EF%BC%89&limit=10Action summary
- Company
- 医療機器産業連合会（医機連）Japanese originalOriginal: 医療機器産業連合会（医機連）
- Entity match
- Possible entity match60/100Machine extractedCompany 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
- Administrative Guidance行政指導
- Action date
- 1 September 2024
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Development of human resources for medical devices, streamlining regulations, international regulatory harmonization, improving certification systems, cybersecurity measures, rationalizing QMS, enhancing registry reliability, promoting work style reforms, advancing electronic applications and digitization, and strengthening collaboration with overseas regulatory authorities.
Show original Japanese text
医療機器の人材育成、規制の合理化、国際規制調和、認証制度の改善、サイバーセキュリティ対策、QMSの合理化、レジストリの信頼性向上、働き方改革の推進、電子申請・電子化の促進、海外規制当局との連携強化。
Compliance context
Low-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.
Use as a monitoring signal. Confirm details before treating it as a formal sanction.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
Evidence pack
- Extracted at
- 2026-04-27T00:01:30.932+00:00
- Evidence checked
- 2026-04-27T00:01:30.932+00:00
- Archive captured
- 2026-04-27T00:01:31.462+00:00
Show audit JSON
{
"record": {
"id": "6a4a1578-0692-40d8-a2e7-61bb6c4bf533",
"url": "https://regbase.jp/en/enforcement/yakkiho-yi-liao-ji-qi-chan-ye-lian-he-huiyi-ji-lian-20240901",
"company_name_original": "医療機器産業連合会（医機連）",
"company_name_registry": "医療機器産業連合会（医機連）",
"corporate_number": null,
"law": {
"ja": "薬機法",
"en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
},
"action_type": {
"ja": "行政指導",
"en": "Administrative Guidance"
},
"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": "Low-medium",
"actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
"practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
"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-huiyi-ji-lian-20240901",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_13968.html",
"archiveUrl": "https://kiroku.today/view/9512ba6ebbgfmie5",
"archiveCapturedAt": "2026-04-27T00:01:31.462+00:00",
"extractedAt": "2026-04-27T00:01:30.932+00:00",
"translatedAt": "2026-05-01T09:42:24.606+00:00",
"evidenceCheckedAt": "2026-04-27T00:01:30.932+00:00",
"generatedAt": "2026-06-19T09:19:33.679Z"
},
"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（医機連） Japanese original
- Japanese name
- 医療機器産業連合会（医機連）
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.