← 所有监管机构
§ EUROPE
Swissmedic
瑞士治疗产品管理局
Switzerland
Last reviewed 2026-06-21
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。
器械分类
Class I, IIa, IIb, III
审批路径
EU CE recognition / Swiss conformity assessment
核心监管职能
- ▸MedDO合规监管
- ▸承认欧盟CE证书
- ▸瑞士市场监督
- ▸MDSAP参与
§ 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.
MedFlux实时监控Swissmedic的监管变化、安全警报和市场信号——让您的团队不错过任何关键更新。
免费监控{abbr} →