§ COMPARE REGULATORS

Swissmedic vs COFEPRIS: Medical Device Regulatory Comparison

Compare the medical device registration pathways, classification, and regulatory requirements of Swissmedic (Switzerland) vs COFEPRIS (Mexico).

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

COFEPRIS

Federal Commission for Protection against Health Risks (Mexico)

Mexico

COFEPRIS regulates medical devices in Mexico under the General Health Law. Mexico uses a three-class system (I, II, III). A sanitary registration (registro sanitario) is required for Class II and III …

CLASSES

Class I, II, III

PATHWAY

COFEPRIS sanitary registration

KEY FUNCTIONS
  • ▸Sanitary registration
  • ▸FDA/EU recognition pathway
  • ▸GMP compliance
  • ▸Import permits
  • ▸Vigilance reporting

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§ OTHER COMPARISONS

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Compare FDA and Health Canada device regulation — MDL vs 510(k), MDSAP single audit, Class IV vs PMA…

FDA vs EMA

Compare FDA 510(k)/PMA with EU MDR CE marking — classification, timelines, costs, QMS requirements, …

FDA vs MHRA

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FDA vs Swissmedic

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