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MHRA vs Swissmedic：医疗器械监管对比
对比 MHRA (United Kingdom) 与 Swissmedic (Switzerland) 的医疗器械注册路径、分类和监管要求。
MHRA
英国药品和医疗产品监管局
United Kingdom
脱欧后，MHRA在英国运营独立的医疗器械监管框架。英国合格评定（UKCA）标志正在取代CE标志。MHRA正在开发与EU MDR不同的独立器械法规框架。…
CLASSES
Class I, IIa, IIb, III
PATHWAY
UKCA marking via UK Approved Body
KEY FUNCTIONS
- ▸UKCA标志
- ▸英国器械注册
- ▸Yellow Card不良事件报告
- ▸英国批准机构监管
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
MedFlux monitors both MHRA and Swissmedic in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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