Skip to main content

Recent Amendments & Consultations

This page tracks significant recent changes to Mexico's medical device regulatory framework. For the most current updates, monitor the Diario Oficial de la Federación (DOF) and the COFEPRIS website.

Published reforms (2024–2026)​

DateInstrumentSummary
January 2026COFEPRIS policy updateSubsequent registration renewals now eligible for periods up to 10 years
September 2025Equivalency Route operationalFast-track route fully operational for all IMDRF/MDSAP authority approvals; 30-working-day target
July 2025DOF classification decreeNew three-Annex framework replaces 2011 and 2014 exemption agreements; updated low-risk device lists
June 2025DOF Acuerdo — RRA expansionFormal expansion of recognised Reference Regulatory Authorities to all IMDRF and MDSAP members
April 2025NOM-241-SSA1-2025New GMP standard enters into force; replaces NOM-241-SSA1-2021

Drafts under consultation / pending finalisation​

InstrumentStatusKey changes
PROY-NOM-240-SSA1-2024Comment period closed Sept 2024; awaiting final publicationDistributor obligations formalised; expanded definitions; companion administrative guide planned
PROY-NOM-137-SSA1-2024In development / comment period completedAlignment with ISO 15223-1:2021; e-IFU provisions; IVD labelling updates

Earlier context​

DateEvent
2014COFEPRIS exemption agreement — prior low-risk device exemption framework (repealed July 2025)
2012NOM-240-SSA1-2012 — Technovigilance (still in force; draft update in progress)
2011COFEPRIS exemption agreement (repealed July 2025)
2008NOM-137-SSA1-2008 — Labelling (still in force; draft update in progress)

How to monitor changes​

  1. DOF (dof.gob.mx) — full text of all NOM publications and COFEPRIS decrees.
  2. COFEPRIS website (gob.mx/cofepris) — announcements and guidance.
  3. INAMEX / industry associations — industry updates and comment period notifications.
  4. RAPath What's New — monitored summary of regulatory changes.