§ COMPARE REGULATORS
MFDS vs SAHPRA：医疗器械监管对比
对比 MFDS (South Korea) 与 SAHPRA (South Africa) 的医疗器械注册路径、分类和监管要求。
MFDS
韩国食品药品安全部
South Korea
MFDS使用四级分类体系监管韩国医疗器械。所有制造商需符合韩国GMP（KGMP）标准。韩国是MDSAP参与国。…
CLASSES
Class I, II, III, IV
PATHWAY
MFDS registration
KEY FUNCTIONS
- ▸KGMP合规
- ▸技术文件审查
- ▸MDSAP参与
- ▸临床试验审批
- ▸器械注册
SAHPRA
SAHPRA — South Africa医疗器械监管机构
South Africa
SAHPRA是South Africa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
Class A, B, C, D
PATHWAY
SAHPRA 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 MFDS and SAHPRA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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