Administrative Guidance against ボストン・サイエンティフィックジャパン株式会社
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/api/v1/enforcements?corporate_number=9011101019705&limit=10Action summary
- Company
- ボストン・サイエンティフィックジャパン株式会社Japanese originalOriginal: ボストン・サイエンティフィックジャパン株式会社Corporate Number: 9011101019705
- 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
- 医薬品医療機器等の品質管理等に関する法律医薬品医療機器等の品質管理等に関する法律
- Action type
- Administrative Guidance行政指導
- Action date
- 4 December 2020
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Product name: S-ICD pulse generator, Quantity shipped: 102 units, Shipping period: from January 27, 2016 to February 23, 2018
Show original Japanese text
販売名:S-ICD パルスジェネレータ、出荷数量:102台、出荷時期:平成28年1月27日から平成30年2月23日まで
Compliance context
Low-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Japanese regulatory disclosure under 医薬品医療機器等の品質管理等に関する法律.
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
- 2026-04-25T00:18:45.547+00:00
- Evidence checked
- 2026-04-25T00:18:45.547+00:00
- Archive captured
- 2026-04-09T06:01:33.442+00:00
Show audit JSON
{
"record": {
"id": "55aa3a5c-c991-41c3-8f05-dbdc082ac4de",
"url": "https://regbase.jp/en/enforcement/other-bosutonsaienteihuitukuziyapan-20201204",
"company_name_original": "ボストン・サイエンティフィックジャパン株式会社",
"company_name_registry": "ボストン・サイエンティフィックジャパン株式会社",
"corporate_number": "9011101019705",
"law": {
"ja": "医薬品医療機器等の品質管理等に関する法律",
"en": "医薬品医療機器等の品質管理等に関する法律"
},
"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": "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": "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": "Japanese regulatory disclosure under 医薬品医療機器等の品質管理等に関する法律."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-bosutonsaienteihuitukuziyapan-20201204",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_15271.html",
"archiveUrl": "https://kiroku.today/view/f3719b66a8r2k82f",
"archiveCapturedAt": "2026-04-09T06:01:33.442+00:00",
"extractedAt": "2026-04-25T00:18:45.547+00:00",
"translatedAt": "2026-05-01T07:07:28.033+00:00",
"evidenceCheckedAt": "2026-04-25T00:18:45.547+00:00",
"generatedAt": "2026-05-20T07:54:34.726Z"
},
"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
- ボストン・サイエンティフィックジャパン株式会社 Japanese original
- Japanese name
- ボストン・サイエンティフィックジャパン株式会社
- Corporate Number
- 9011101019705
- Registered address
- 東京都中野区中野4丁目10番2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.