Possible 承認 against ロシュ・ダイアグノスティクス株式会社
For developers: 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=10Action summary
- Company
- ロシュ・ダイアグノスティクス株式会社Japanese originalOriginal: ロシュ・ダイアグノスティクス株式会社
- Entity match
- Possible entity match60/100Machine extractedCompany 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
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 neededThis 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
- 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": "2026-06-19T09:15:40.158Z"
},
"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.
Language
日本語版を見る (Japanese)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
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.