Enforcement record

指定 disclosure naming 第一医科株式会社

第一医科株式会社 (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

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-YAKKIHO-DI-YI-YI--202608041528
Generated at: 5 August 2026 at 00:28
Record URL: https://regbase.jp/en/enforcement/yakkiho-di-yi-yi-ke-20170228

1. Review Summary

Disclosure name	第一医科株式会社	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	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices	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	第一医科株式会社

3. Enforcement Record

Target name in disclosure	第一医科株式会社
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices / 指定
Action / announcement date	Action: 28 February 2017 / Announcement: 2 May 2026
English summary	First Medical Corporation was designated by the Ministry of Health, Labour and Welfare under the Pharmaceutical and Medical Device Act (薬機法) on February 28, 2017. The designation pertains to a medical device that is implanted at tracheal defect sites, with the novelty and high pioneering nature of maintaining tracheal structure and serving as a scaffold for mucosal reconstruction.
Original Japanese text	気管欠損部位に留置し、気管の構造を保ち粘膜再建の足場となる点に新規性があり、画期性が高い。
Official source	https://www.mhlw.go.jp/stf/houdou/0000153128.html
Source archive	https://kiroku.today/a/60d0baf7afoak2ny
Extraction / evidence timestamps	Extracted: 2 May 2026 at 21:01 / Evidence checked: 2 May 2026 at 21:01 / Archive captured: 2 May 2026 at 21:01

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

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Free report

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Preserved evidence by Kiroku

Review the preserved source for 第一医科株式会社

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Open preserved source and evidence pack

For developers: JSON integration details

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/api/v1/enforcements?company=%E7%AC%AC%E4%B8%80%E5%8C%BB%E7%A7%91%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Open JSON Specs

Action summary

Company: 第一医科株式会社Japanese only
Original: 第一医科株式会社
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

First Medical Corporation was designated by the Ministry of Health, Labour and Welfare under the Pharmaceutical and Medical Device Act (薬機法) on February 28, 2017. The designation pertains to a medical device that is implanted at tracheal defect sites, with the novelty and high pioneering nature of maintaining tracheal structure and serving as a scaffold for mucosal reconstruction.

Show original Japanese text

気管欠損部位に留置し、気管の構造を保ち粘膜再建の足場となる点に新規性があり、画期性が高い。

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: 2026-05-02T12:01:46.652+00:00
Evidence checked: 2026-05-02T12:01:46.652+00:00
Archive captured: 2026-05-02T12:01:57.351371+00:00

Show audit JSON

{
  "record": {
    "id": "154f8150-abfd-411e-a432-8759f1c2e974",
    "url": "https://regbase.jp/en/enforcement/yakkiho-di-yi-yi-ke-20170228",
    "company_name_original": "第一医科株式会社",
    "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 (第一医科株式会社). 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-di-yi-yi-ke-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": "2026-05-02T12:01:46.652+00:00",
    "translatedAt": "2026-07-06T07:51:58.858+00:00",
    "evidenceCheckedAt": "2026-05-02T12:01:46.652+00:00",
    "generatedAt": "2026-08-04T15:28:19.543Z"
  },
  "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.