← 所有监管机构
§ EUROPE
BfArM
BfArM — Germany医疗器械监管机构
Germany
Last reviewed 2026-06-21
BfArM是Germany负责医疗器械监管的国家监管机构，负责器械注册、市场监督和不良事件报告。
器械分类
EU MDR classes
审批路径
BfArM registration
核心监管职能
- ▸器械注册
- ▸市场监督
- ▸不良事件报告
- ▸进出口管控
§ 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实时监控BfArM的监管变化、安全警报和市场信号——让您的团队不错过任何关键更新。
免费监控{abbr} →