Possible Recommendation against 医療機器産業界
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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%E7%95%8C&limit=10Action summary
- Company
- 医療機器産業界Japanese originalOriginal: 医療機器産業界
- 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
- Recommendation勧告
- Action date
- 27 August 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Recommendations and requests regarding streamlining regulations, work style reform, promotion of medical device development, cybersecurity, improvement of certification systems, and strengthening of medical safety measures.
Show original Japanese text
規制の効率化、働き方改革、医療機器の開発促進、サイバーセキュリティ、認証制度の改善、医療安全対策の強化に関する提言と要望。
Compliance context
MediumA 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
- Extracted at
- 2026-04-25T00:20:38.774+00:00
- Evidence checked
- 2026-04-25T00:20:38.774+00:00
- Archive captured
- 2026-04-10T00:00:55.219+00:00
Show audit JSON
{
"record": {
"id": "08582db4-3a01-42d9-a4f1-76103c8d6871",
"url": "https://regbase.jp/en/enforcement/yakkiho-yi-liao-ji-qi-chan-ye-jie-20210827",
"company_name_original": "医療機器産業界",
"company_name_registry": "医療機器産業界",
"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-jie-20210827",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21919.html",
"archiveUrl": "https://kiroku.today/view/2077ea6711ijow9q",
"archiveCapturedAt": "2026-04-10T00:00:55.219+00:00",
"extractedAt": "2026-04-25T00:20:38.774+00:00",
"translatedAt": "2026-05-01T07:08:59.724+00:00",
"evidenceCheckedAt": "2026-04-25T00:20:38.774+00:00",
"generatedAt": "2026-06-19T08:23:17.934Z"
},
"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)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.