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
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
- Queued for preservation
- Captured: Jul 12, 2026, 04:04 PM JST
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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.
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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.