{
  "record": {
    "id": "bdb870a2-dc6a-43ea-b217-de332a32d03a",
    "url": "https://regbase.jp/en/enforcement/yakkiho-rosiyudaiagunosuteitukusu-20220817",
    "company_name_original": "ロシュ・ダイアグノスティックス株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "承認",
      "en": "承認"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 85,
    "method": "nta_strict_name_nationally_unique",
    "method_label": "nta_strict_name_nationally_unique",
    "notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (ロシュ・ダイアグノスティックス株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-rosiyudaiagunosuteitukusu-20220817",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_28612.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/b6c75c64b9hv28sk",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_28612.html",
    "archiveCapturedAt": "2026-04-28T00:01:32.613498+00:00",
    "extractedAt": "2026-05-05T00:00:55.957+00:00",
    "translatedAt": "2026-07-06T07:42:17.502+00:00",
    "evidenceCheckedAt": "2026-05-05T00:00:55.957+00:00",
    "generatedAt": "2026-08-18T22:08:39.747Z"
  },
  "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."
  ]
}