§ COMPARE REGULATORS
Swissmedic vs BfArM：医疗器械监管对比
对比 Swissmedic (Switzerland) 与 BfArM (Germany) 的医疗器械注册路径、分类和监管要求。
Swissmedic
瑞士治疗产品管理局
Switzerland
Swissmedic根据修订后的医疗器械条例（MedDO）监管瑞士医疗器械，该条例与EU MDR基本一致。瑞士承认大多数器械类别的欧盟CE证书。…
CLASSES
Class I, IIa, IIb, III
PATHWAY
EU CE recognition / Swiss conformity assessment
KEY FUNCTIONS
- ▸MedDO合规监管
- ▸承认欧盟CE证书
- ▸瑞士市场监督
- ▸MDSAP参与
BfArM
BfArM — Germany医疗器械监管机构
Germany
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。…
CLASSES
EU MDR classes
PATHWAY
BfArM registration
KEY FUNCTIONS
- ▸器械注册
- ▸市场监督
- ▸不良事件报告
- ▸进出口管控
MedFlux monitors both Swissmedic and BfArM in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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