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

ボストン・サイエンティフィックジャパン株式会社 (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Ministry of Health, Labour and WelfareConfirmed entity match4 December 2020
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/api/v1/enforcements?corporate_number=9011101019705&limit=10

Action summary

Company
Original: 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 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
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

Machine-translated summary — verify against original

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-medium

Administrative 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

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot
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.

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
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.