Swissmedic vs INVIMA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of Swissmedic (Switzerland) vs INVIMA (Colombia).
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
INVIMA
INVIMA — Colombia Medical Device Regulatory Authority
Colombia
INVIMA is the national regulatory authority responsible for medical device oversight in Colombia. It manages device registration, market surveillance, and adverse event reporting within the Latin Amer…
Class I, IIa, IIb, III
INVIMA registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
MedFlux monitors both Swissmedic and INVIMA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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