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 (Pharmaceutical Affairs Act)

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

Pharmaceutical Affairs ActMinistry of Health, Labour and WelfareGovernment disclosure28 February 2017

Action type

指定

Law

Pharmaceutical Affairs Act

Authority

Ministry of Health, Labour and Welfare

Action date

28 February 2017

RegBase evidence report

Japanese public-record enforcement check

Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.

Report ID: RB-EN-ENFORCEMENT-OTHER-SISUMETUKUS-202608041628
Generated at: 5 August 2026 at 01:28
Record URL: https://regbase.jp/en/enforcement/other-sisumetukusu-20170228

1. Review Summary

Disclosure name	シスメックス株式会社	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	28 February 2017	Authority	Ministry of Health, Labour and Welfare
Law	Pharmaceutical Affairs Act	Action type	指定
Source status	Preserved public-source archive recorded

This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.

2. Published Information

Published name	シスメックス株式会社

3. Enforcement Record

Target name in disclosure	シスメックス株式会社
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	Pharmaceutical Affairs Act / 指定
Action / announcement date	Action: 28 February 2017 / Announcement: 7 April 2026
English summary	A DNA sequencer diagnostic system that comprehensively tests for mutations, amplifications, and fusions of cancer-related genes, used for genetic abnormality profiling of cancer patients and assisting in clinical decision-making. There are no domestically approved products, and future plans include conducting necessary tests to substantiate the usefulness of cancer-related gene abnormality profiling and submitting an approval application in Japan ahead of the world.
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であり、がん患者の遺伝子異常プロファイリングを行い、診療方針決定の補助に用いる。国内で承認されたものがなく、今後、がん関連遺伝子異常プロファイリングの有用性を裏付けるために必要な試験を行い、世界に先駆けて日本で承認申請予定。
Official source	https://www.mhlw.go.jp/stf/houdou/0000153128.html
Source archive	https://kiroku.today/a/60d0baf7afhg2xss
Extraction / evidence timestamps	Extracted: 25 April 2026 at 09:13 / Evidence checked: 25 April 2026 at 09:13 / Archive captured: 12 July 2026 at 16:04

4. Business Location and Permit Details

No additional structured business-location or permit fields are recorded for this disclosure.

5. Other Confirmed Records for This Company

This report covers the single government disclosure shown on this page.

Reviewer Notes

Reviewer		Team / company
Review purpose
Additional notes

□ Official source URL or archived source was checked.
□ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
□ This document is understood as a public-record evidence file, not a credit decision or legal opinion.

Current page: Enforcement record

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

Free report

Save the disclosure record naming シスメックス株式会社

Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.

Preserved evidence by Kiroku

Review the preserved source for シスメックス株式会社

Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.

Open preserved source and evidence pack

For developers: JSON integration details

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/api/v1/enforcements?company=%E3%82%B7%E3%82%B9%E3%83%A1%E3%83%83%E3%82%AF%E3%82%B9%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Open JSON Specs

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: Pharmaceutical Affairs Act
薬事法
Action type: 指定
指定
Action date: 28 February 2017
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

A DNA sequencer diagnostic system that comprehensively tests for mutations, amplifications, and fusions of cancer-related genes, used for genetic abnormality profiling of cancer patients and assisting in clinical decision-making. There are no domestically approved products, and future plans include conducting necessary tests to substantiate the usefulness of cancer-related gene abnormality profiling and submitting an approval application in Japan ahead of the world.

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であり、がん患者の遺伝子異常プロファイリングを行い、診療方針決定の補助に用いる。国内で承認されたものがなく、今後、がん関連遺伝子異常プロファイリングの有用性を裏付けるために必要な試験を行い、世界に先駆けて日本で承認申請予定。

Compliance context

Context needed

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

Japanese regulatory disclosure under Pharmaceutical Affairs Act.

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: 2026-04-25T00:13:59.114+00:00
Evidence checked: 2026-04-25T00:13:59.114+00:00
Archive captured: 2026-07-12T07:04:38.252332+00:00

Show audit JSON

{
  "record": {
    "id": "93131601-30a9-453c-8b20-8b885d6c46d1",
    "url": "https://regbase.jp/en/enforcement/other-sisumetukusu-20170228",
    "company_name_original": "シスメックス株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "薬事法",
      "en": "Pharmaceutical Affairs Act"
    },
    "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": "Japanese regulatory disclosure under Pharmaceutical Affairs Act."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-sisumetukusu-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/60d0baf7afhg2xss",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveCapturedAt": "2026-07-12T07:04:38.252332+00:00",
    "extractedAt": "2026-04-25T00:13:59.114+00:00",
    "translatedAt": "2026-05-01T07:03:42.556+00:00",
    "evidenceCheckedAt": "2026-04-25T00:13:59.114+00:00",
    "generatedAt": "2026-08-04T16:28:40.869Z"
  },
  "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.