What's Changed? On 19 May 2026, Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) published the final version of NOM-137-SSA1-2025, the country's updated labelling standard for medical devices. The new standard introduces important revisions to labelling and Instructions for Use (IFU) requirements, updates key regulatory definitions, clarifies manufacturer responsibilities, and aligns several provisions more closely with internationally recognis

Brazil: Requirements finalized for custom-made and patient-specific medical devices Brazil: Proposed changes to requirements for syringes...

Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices Ecuador: Proposed revision of PRTE INEN No...