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Swissmedic
瑞士治療產品管理局
Switzerland
Last reviewed 2026-06-21
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。
器材分類
Class I, IIa, IIb, III
審批路徑
EU CE recognition / Swiss conformity assessment
核心監管職能
- ▸MedDO合規監管
- ▸承認歐盟CE證書
- ▸瑞士市場監督
- ▸MDSAP參與
§ FAQ
Does Switzerland accept CE marking for medical devices?
Switzerland recognizes EU CE certificates for most medical device classes under the Mutual Recognition Agreement (MRA) with the EU, which was updated to reflect the EU MDR transition. However, manufacturers still need to register their devices with Swissmedic and comply with the Swiss Medical Devices Ordinance (MedDO), which is largely aligned with EU MDR.
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