§ COMPARE REGULATORS

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

CLASSES

Class I, IIa, IIb, III

PATHWAY

EU CE recognition / Swiss conformity assessment

KEY FUNCTIONS
  • 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

CLASSES

Class I, IIa, IIb, III

PATHWAY

INVIMA registration

KEY FUNCTIONS
  • 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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§ OTHER COMPARISONS