{"data":[{"id":"a15ddadc-cef1-47a7-8c28-ab0a8b6fd653","company_name":"第一医科 株式会社","company_name_en":null,"corporate_number":"1010001004353","authority":"厚生労働省","law_name":"薬事法","action_type":"先駆け審査指定制度対象品目の募集","action_date":"2017-10-05","announcement_date":"2026-04-03","violation_summary":"人工気管 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り 、気管欠損部を狭窄なく代替","violation_summary_en":"Placed artificial trachea in the tracheal defect site to maintain tracheal structure, serve as a scaffold for mucosal reconstruction, and replace the tracheal defect without stenosis.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000179802.html","url":"https://regbase.jp/enforcement/other-di-yi-yi-ke-20171005"},{"id":"09df882a-0635-4bac-8caf-cc8d59442640","company_name":"第一医科株式会社","company_name_en":null,"corporate_number":"1010001004353","authority":"厚生労働省","law_name":"薬事法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-04-07","violation_summary":"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。","violation_summary_en":"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.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/other-di-yi-yi-ke-20170228"},{"id":"154f8150-abfd-411e-a432-8759f1c2e974","company_name":"第一医科株式会社","company_name_en":null,"corporate_number":"1010001004353","authority":"厚生労働省","law_name":"薬機法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-05-02","violation_summary":"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。","violation_summary_en":null,"penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/yakkiho-di-yi-yi-ke-20170228"}],"meta":{"query":null,"corporate_number":"1010001004353","law":null,"authority":null,"action_type":null,"count":3,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":8,"reset_at":"2026-05-21T23:35:07.316Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":260,"reset_at":"2026-05-22T23:34:07.316Z"}}}