Enforcement record
指定 disclosure naming 第一医科株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
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-DI-YI-YI-KE-202608041727
- Generated at
- 5 August 2026 at 02:27
- Record URL
- https://regbase.jp/en/enforcement/other-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 | 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 | 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 | Pharmaceutical Affairs Act / 指定 |
| Action / announcement date | Action: 28 February 2017 / Announcement: 7 April 2026 |
| English summary | The device is novel and highly innovative in that it is implanted in the tracheal defect site to maintain the structure of the trachea and serve as a scaffold for mucosal reconstruction. Clinical research (12 cases) suggests high efficacy in all cases, with results indicating the preservation of morphological and functional tracheal functions. After domestic clinical trials, it is planned to apply for approval in Japan ahead of the rest of the world. |
| 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。臨床研究（12例）により、全例で高い有効性を示唆する結果（形態的・機能的に気管としての機能を保っている。）との報告がある。国内での治験を経て、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/60d0baf7afhg2xrd |
| 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 第一医科株式会社
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 第一医科株式会社
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For developers: JSON integration details
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Action summary
- Company
- 第一医科株式会社Japanese onlyOriginal: 第一医科株式会社
- 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
The device is novel and highly innovative in that it is implanted in the tracheal defect site to maintain the structure of the trachea and serve as a scaffold for mucosal reconstruction. Clinical research (12 cases) suggests high efficacy in all cases, with results indicating the preservation of morphological and functional tracheal functions. After domestic clinical trials, it is planned to apply for approval in Japan ahead of the rest of the world.
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。臨床研究（12例）により、全例で高い有効性を示唆する結果（形態的・機能的に気管としての機能を保っている。）との報告がある。国内での治験を経て、世界に先駆けて日本で承認申請予定。
Compliance context
Context neededThis 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
- Extracted at
- 2026-04-25T00:13:58.296+00:00
- Evidence checked
- 2026-04-25T00:13:58.296+00:00
- Archive captured
- 2026-07-12T07:04:18.451295+00:00
Show audit JSON
{
"record": {
"id": "09df882a-0635-4bac-8caf-cc8d59442640",
"url": "https://regbase.jp/en/enforcement/other-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 (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": "Japanese regulatory disclosure under Pharmaceutical Affairs Act."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-di-yi-yi-ke-20170228",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/60d0baf7afhg2xrd",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
"archiveCapturedAt": "2026-07-12T07:04:18.451295+00:00",
"extractedAt": "2026-04-25T00:13:58.296+00:00",
"translatedAt": "2026-05-01T07:03:37.435+00:00",
"evidenceCheckedAt": "2026-04-25T00:13:58.296+00:00",
"generatedAt": "2026-08-04T17:27:22.079Z"
},
"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.