Swissmedic vs ISP: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of Swissmedic (Switzerland) vs ISP (Chile).
Swissmedic
Swiss Agency for Therapeutic Products
Switzerland
Swissmedic regulates medical devices in Switzerland under the revised Medical Devices Ordinance (MedDO), which is largely aligned with EU MDR. Switzerland recognizes EU CE certificates for most device…
Class I, IIa, IIb, III
EU CE recognition / Swiss conformity assessment
- ▸MedDO compliance oversight
- ▸Recognition of EU CE certificates
- ▸Swiss market surveillance
- ▸MDSAP participation
ISP
ISP — Chile Medical Device Regulatory Authority
Chile
ISP is the national regulatory authority responsible for medical device oversight in Chile. It manages device registration, market surveillance, and adverse event reporting within the Latin America re…
Class I, II, III, IV
ISP registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
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