Possible 承認 against ロシュ・ダイアグノスティクス株式会社

ロシュ・ダイアグノスティクス株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfarePossible entity match17 August 2022
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/api/v1/enforcements?company=%E3%83%AD%E3%82%B7%E3%83%A5%E3%83%BB%E3%83%80%E3%82%A4%E3%82%A2%E3%82%B0%E3%83%8E%E3%82%B9%E3%83%86%E3%82%A3%E3%82%AF%E3%82%B9%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Action summary

Company
Original: ロシュ・ダイアグノスティクス株式会社
Entity match
Possible entity match60/100Machine extracted
Company name extracted from the Japanese public disclosure
Governing law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type
承認
承認
Action date
17 August 2022
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

The OTC approval for the COVID-19 antigen test kit was granted promptly. Thank you very much.

Show original Japanese text

新型コロナウイルス抗原検査キットのOTC化を迅速に承認していただきました。誠にありがとうございました。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

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
2026-04-25T00:27:07.003+00:00
Evidence checked
2026-04-25T00:27:07.003+00:00
Archive captured
2026-06-14T06:30:29.138+00:00
Show audit JSON
{
  "record": {
    "id": "adce976a-17a8-49aa-b272-4397eaa7361f",
    "url": "https://regbase.jp/en/enforcement/yakkiho-rosiyudaiagunosuteikusu-20220817",
    "company_name_original": "ロシュ・ダイアグノスティクス株式会社",
    "company_name_registry": "ロシュ・ダイアグノスティクス株式会社",
    "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": "possible",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": null
  },
  "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-rosiyudaiagunosuteikusu-20220817",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_28612.html",
    "archiveUrl": "https://kiroku.today/view/b6c75c64b9dennb8",
    "archiveCapturedAt": "2026-06-14T06:30:29.138+00:00",
    "extractedAt": "2026-04-25T00:27:07.003+00:00",
    "translatedAt": "2026-05-01T07:14:53.47+00:00",
    "evidenceCheckedAt": "2026-04-25T00:27:07.003+00:00",
    "generatedAt": "2026-06-19T10:41:27.456Z"
  },
  "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
ロシュ・ダイアグノスティクス株式会社 Japanese original
Japanese name
ロシュ・ダイアグノスティクス株式会社
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.