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.
| Date | Instrument | Summary |
|---|
| January 2026 | COFEPRIS policy update | Subsequent registration renewals now eligible for periods up to 10 years |
| September 2025 | Equivalency Route operational | Fast-track route fully operational for all IMDRF/MDSAP authority approvals; 30-working-day target |
| July 2025 | DOF classification decree | New three-Annex framework replaces 2011 and 2014 exemption agreements; updated low-risk device lists |
| June 2025 | DOF Acuerdo — RRA expansion | Formal expansion of recognised Reference Regulatory Authorities to all IMDRF and MDSAP members |
| April 2025 | NOM-241-SSA1-2025 | New GMP standard enters into force; replaces NOM-241-SSA1-2021 |
Drafts under consultation / pending finalisation
| Instrument | Status | Key changes |
|---|
| PROY-NOM-240-SSA1-2024 | Comment period closed Sept 2024; awaiting final publication | Distributor obligations formalised; expanded definitions; companion administrative guide planned |
| PROY-NOM-137-SSA1-2024 | In development / comment period completed | Alignment with ISO 15223-1:2021; e-IFU provisions; IVD labelling updates |
Earlier context
| Date | Event |
|---|
| 2014 | COFEPRIS exemption agreement — prior low-risk device exemption framework (repealed July 2025) |
| 2012 | NOM-240-SSA1-2012 — Technovigilance (still in force; draft update in progress) |
| 2011 | COFEPRIS exemption agreement (repealed July 2025) |
| 2008 | NOM-137-SSA1-2008 — Labelling (still in force; draft update in progress) |
How to monitor changes
- DOF (dof.gob.mx) — full text of all NOM publications and COFEPRIS decrees.
- COFEPRIS website (gob.mx/cofepris) — announcements and guidance.
- INAMEX / industry associations — industry updates and comment period notifications.
- RAPath What's New — monitored summary of regulatory changes.
Related pages
January 2026 | COFEPRIS policy update | Subsequent registration renewals now eligible for periods up to 10 years (previously 5 years). This applies to renewal applications submitted after January 2026; initial registrations remain on the standard 5-year term. Transition details for registrations with expiry dates before December 2027 are available on the COFEPRIS website.