§ COMPARE REGULATORS

COFEPRIS vs SFDA: Medical Device Regulatory Comparison

Compare the medical device registration pathways, classification, and regulatory requirements of COFEPRIS (Mexico) vs SFDA (Saudi Arabia).

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

SFDA

Saudi Food and Drug Authority

Saudi Arabia

The SFDA regulates medical devices in Saudi Arabia under the Medical Devices Interim Regulation. Saudi Arabia is increasingly aligning with international standards (IMDRF) and has introduced mandatory…

CLASSES

Class A, B, C, D

PATHWAY

SFDA device listing / market authorization

KEY FUNCTIONS
  • ▸Device listing (MDMA)
  • ▸Conformity assessment
  • ▸Adverse event reporting
  • ▸GCC harmonization
  • ▸Import control

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