§ COMPARE REGULATORS
Swissmedic vs SAHPRA：醫療器材監管對比
對比 Swissmedic (Switzerland) 與 SAHPRA (South Africa) 的醫療器材註冊路徑、分類和監管要求。
Swissmedic
瑞士治療產品管理局
Switzerland
Swissmedic根據修訂後的醫療器材條例（MedDO）監管瑞士醫療器材，該條例與EU MDR基本一致。瑞士承認大多數器材類別的歐盟CE證書。…
CLASSES
Class I, IIa, IIb, III
PATHWAY
EU CE recognition / Swiss conformity assessment
KEY FUNCTIONS
- ▸MedDO合規監管
- ▸承認歐盟CE證書
- ▸瑞士市場監督
- ▸MDSAP參與
SAHPRA
SAHPRA — South Africa醫療器材監管機構
South Africa
SAHPRA是South Africa負責醫療器材監管的國家監管機構，負責器材註冊、市場監督和不良事件報告。…
CLASSES
Class A, B, C, D
PATHWAY
SAHPRA registration
KEY FUNCTIONS
- ▸器材註冊
- ▸市場監督
- ▸不良事件報告
- ▸進出口管控
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