Business Improvement Order against 日本メドトロニック株式会社
For developers: integration details
You do not need this for normal browsing. Use it when integrating this enforcement record into an internal tool or AI workflow.
/api/v1/enforcements?corporate_number=9010401064015&limit=10Action summary
- Company
- 日本メドトロニック株式会社Japanese originalOriginal: 日本メドトロニック株式会社Corporate Number: 9010401064015
- Entity match
- Confirmed entity match95/100Machine extractedNormalized Japanese name matched to a company profile with Corporate NumberMatched by normalized Japanese company name to an enriched company profile with a Corporate Number.
- Governing law
- 医薬品医療機器等法医薬品医療機器等法
- Action type
- Business Improvement Order業務改善命令
- Action date
- 8 November 2024
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Adverse event cases related to foreign medical devices subject to reporting obligations were not reported within the specified deadline.
Show original Japanese text
副作用等報告義務の対象となる外国医療機器の不具合症例が定められた期限内に報告されていなかった
Compliance context
Medium-highA formal order requiring business process or compliance control improvements.
Japanese regulatory disclosure under 医薬品医療機器等法.
Ask for remediation evidence if the company is material to your compliance, finance, or customer-facing operations.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
Evidence pack
- Extracted at
- 2026-04-24T23:37:14.726+00:00
- Evidence checked
- 2026-04-24T23:37:14.726+00:00
- Archive captured
- 2026-04-03T12:30:51.752+00:00
Show audit JSON
{
"record": {
"id": "9e176f56-ffc7-42b6-809a-47293025899f",
"url": "https://regbase.jp/en/enforcement/other-ri-ben-medotoronituku-20241108",
"company_name_original": "日本メドトロニック株式会社",
"company_name_registry": "日本メドトロニック株式会社",
"corporate_number": "9010401064015",
"law": {
"ja": "医薬品医療機器等法",
"en": "医薬品医療機器等法"
},
"action_type": {
"ja": "業務改善命令",
"en": "Business Improvement Order"
},
"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-high",
"actionMeaning": "A formal order requiring business process or compliance control improvements.",
"practicalNote": "Ask for remediation evidence if the company is material to your compliance, finance, or customer-facing operations.",
"lawContext": "Japanese regulatory disclosure under 医薬品医療機器等法."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-ri-ben-medotoronituku-20241108",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_45109.html",
"archiveUrl": "https://kiroku.today/view/df43c8c031ivtrg0",
"archiveCapturedAt": "2026-04-03T12:30:51.752+00:00",
"extractedAt": "2026-04-24T23:37:14.726+00:00",
"translatedAt": "2026-05-01T06:51:35.452+00:00",
"evidenceCheckedAt": "2026-04-24T23:37:14.726+00:00",
"generatedAt": "2026-05-20T07:55:16.080Z"
},
"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
- 日本メドトロニック株式会社 Japanese original
- Japanese name
- 日本メドトロニック株式会社
- Corporate Number
- 9010401064015
- Registered address
- 東京都港区港南1丁目2番70号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.