§ COMPARE REGULATORS

HSA vs COFEPRIS: Medical Device Regulatory Comparison

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

HSA

Health Sciences Authority (Singapore)

Singapore

Singapore's HSA regulates medical devices using a four-class risk-based system (A, B, C, D). HSA accepts conformity assessment from recognized bodies and is a founding member of IMDRF. Singapore serve…

CLASSES

Class A, B, C, D

PATHWAY

HSA registration

KEY FUNCTIONS
  • ▸Device registration (Class B-D)
  • ▸Class A dealer license
  • ▸GN-13 guidance compliance
  • ▸Adverse event reporting
  • ▸IMDRF 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

FDA vs Health Canada

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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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