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BfArM
BfArM — Germany醫療器材監管機構
Germany
Last reviewed 2026-06-21
BfArM是Germany負責醫療器材監管的國家監管機構，負責器材註冊、市場監督和不良事件報告。
器材分類
EU MDR classes
審批路徑
BfArM registration
核心監管職能
- ▸器材註冊
- ▸市場監督
- ▸不良事件報告
- ▸進出口管控
§ RELATED INTELLIGENCE
§ FAQ
What is BfArM in Germany?
BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) is Germany's Federal Institute for Drugs and Medical Devices. It serves as the national competent authority for medical device market surveillance under EU MDR, manages the German device registration database, and coordinates vigilance reporting. BfArM does not issue CE certificates — that is the role of EU Notified Bodies.
MedFlux即時監控BfArM的監管變化、安全警報和市場信號——讓您的團隊不錯過任何關鍵更新。
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