Enforcement record

承認 disclosure naming 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)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure17 August 2022

Action type

承認

Law

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

Authority

Ministry of Health, Labour and Welfare

Action date

17 August 2022

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

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Preserved evidence by Kiroku

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Open preserved source and evidence pack
For developers: JSON integration details

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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
ロシュ・ダイアグノスティクス株式会社Japanese only
Original: ロシュ・ダイアグノスティクス株式会社
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 source (Japanese)Open preserved source and evidence pack
Extracted at
2026-04-25T00:27:07.003+00:00
Evidence checked
2026-04-25T00:27:07.003+00:00
Archive captured
2026-06-14T06:33:22.917361+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": 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": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": "The linked company profile has not been verified under the current identity policy."
  },
  "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",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/b6c75c64b9dennb8",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_28612.html",
    "archiveCapturedAt": "2026-06-14T06:33:22.917361+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": "2026-08-04T15:29:36.701Z"
  },
  "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.

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.