Enforcement record

指定 disclosure naming シスメックス株式会社

シスメックス株式会社 (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 disclosure28 February 2017

Action type

指定

Law

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

Authority

Ministry of Health, Labour and Welfare

Action date

28 February 2017

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: May 2, 2026, 09:01 PM 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: シスメックス株式会社Japanese only
Original: シスメックス株式会社
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: 指定
指定
Action date: 28 February 2017
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医療機器

Violation

Machine-translated summary — verify against original

On February 28, 2017, the Ministry of Health, Labour and Welfare designated a DNA sequencer diagnostic system that comprehensively tests for mutations, amplifications, and fusions in cancer-related genes, under the Pharmaceutical and Medical Device Act. The system is classified as a medical device.

Show original Japanese text

がん関連遺伝子の変異・増幅・融合を網羅的に検査するDNAシークエンサー診断システム。

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: 2026-05-02T12:01:51.393+00:00
Evidence checked: 2026-05-02T12:01:51.393+00:00
Archive captured: 2026-05-02T12:01:57.351371+00:00

Show audit JSON

{
  "record": {
    "id": "7d168af1-23d4-4495-af19-c02d180aa9b8",
    "url": "https://regbase.jp/en/enforcement/yakkiho-sisumetukusu-20170228",
    "company_name_original": "シスメックス株式会社",
    "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": "指定",
      "en": "指定"
    },
    "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 (シスメックス株式会社). 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-sisumetukusu-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/60d0baf7afoak2ny",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveCapturedAt": "2026-05-02T12:01:57.351371+00:00",
    "extractedAt": "2026-05-02T12:01:51.393+00:00",
    "translatedAt": "2026-07-06T07:51:49.992+00:00",
    "evidenceCheckedAt": "2026-05-02T12:01:51.393+00:00",
    "generatedAt": "2026-09-18T20:59:20.040Z"
  },
  "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.