Enforcement record

承認 disclosure naming ロシュ・ダイアグノスティックス株式会社

ロシュ・ダイアグノスティックス株式会社 (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.

Source verification

Public-source and preservation status

Publishing authority: Ministry of Health, Labour and Welfare
Official source URL: Recorded by RegBase
Entity match: Not confirmed; shown under the published name
Kiroku preservation: Completed archive verified; Captured: Apr 28, 2026, 09:01 AM JST

“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.

Open the official source links in the section below to review the original disclosure.

Action summary

Company: ロシュ・ダイアグノスティックス株式会社Japanese only
Original: ロシュ・ダイアグノスティックス株式会社
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
Industry context: 医療機器・体外診断薬

Violation

Machine-translated summary — verify against original

Roche Diagnostics Corporation received approval under the Pharmaceutical and Medical Device Act (PMDA) on August 17, 2022, for the OTC designation of a COVID-19 antigen test kit. The approval process was expedited, and the product has begun online sales, indicating a swift progression in market availability.

Show original Japanese text

インターネットを介しての販売も開始されている状況で、迅速に進んでいる状況です。

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.

Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-05-05T00:00:55.957+00:00
Evidence checked: 2026-05-05T00:00:55.957+00:00
Archive captured: 2026-04-28T00:01:32.613498+00:00

Show audit JSON

{
  "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": "2026-10-05T14:18:33.492Z"
  },
  "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)

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