Business Improvement Order against 日本メドトロニック株式会社

日本メドトロニック株式会社 (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and WelfareConfirmed entity match8 November 2024
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/api/v1/enforcements?corporate_number=9010401064015&limit=10

Action summary

Company
Original: 日本メドトロニック株式会社
Corporate Number: 9010401064015
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

Machine-translated summary — verify against original

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-high

A 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

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

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
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.