§ COMPARE REGULATORS
Swissmedic vs TGA：医疗器械监管对比
对比 Swissmedic (Switzerland) 与 TGA (Australia) 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
TGA
澳大利亚治疗产品管理局
Australia
TGA根据1989年《治疗产品法》监管澳大利亚医疗器械。澳大利亚使用与GHTF/IMDRF一致的风险分类体系。TGA是MDSAP参与机构。…
CLASSES
Class I, IIa, IIb, III, AIMD
PATHWAY
ARTG inclusion via conformity assessment
KEY FUNCTIONS
- ▸ARTG注册
- ▸合格性评估
- ▸MDSAP参与
- ▸不良事件报告
- ▸上市后监管
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