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Lifecycle of a Medical Device in Mexico

This page provides an overview of the regulatory journey of a medical device in Mexico from initial classification through to post-market maintenance and registration renewal.

Phase 1 — Classify your device​

Before any submission, determine your device's risk class under the Reglamento de Insumos para la Salud:

  • Class I — low risk (some require registration, some are exempt — see Annexes 1–3).
  • Class II — medium risk.
  • Class III — high risk (implants, life-sustaining devices).

Check whether your device appears in the July 2025 classification decree Annexes, which may exempt it from registration entirely (Annex 2) or classify it as a non-health supply (Annex 3).

Phase 2 — Appoint a Mexico Registration Holder (MRH)​

If you are a foreign manufacturer, appoint an MRH before submitting any application. The MRH must be a legally constituted Mexican entity holding a power of attorney from you.

Phase 3 — Choose your registration route​

RouteWhen to use
Standard RouteNo relevant foreign approval, or device is not identical to an approved foreign version
Equivalency (Abbreviated) RouteDevice already approved by FDA, Health Canada, EU MDR, TGA, or another IMDRF/MDSAP authority

Phase 4 — Prepare and submit your dossier​

Submit via the DIGIPRiS portal. The dossier contents vary by class and route:

  • Standard route: full technical file, clinical evidence, GMP certificate (NOM-241 / ISO 13485), Spanish-language labelling, proof of fee payment.
  • Equivalency route: Certificate of Free Sale from reference authority, abbreviated technical summary, labelling.

Phase 5 — COFEPRIS review​

COFEPRIS reviews the dossier and may request additional information. Target timelines:

  • Equivalency route: 30 working days.
  • Standard route: 20–180 working days depending on class.

On approval, COFEPRIS issues a sanitary registration with a unique homoclave (registration code) and lists the device on the COFEPRIS website.

Phase 6 — Post-market obligations begin​

Once registered, ongoing obligations include:

  • Maintaining a technovigilance unit (NOM-240).
  • Reporting adverse events to CNFV within mandated timeframes.
  • Complying with NOM-241 GMP requirements.
  • Keeping labelling compliant with NOM-137.
  • Maintaining distribution records.

Phase 7 — Registration renewal​

Sanitary registrations are valid for 5 years. Renewal requires:

  • First renewal: comprehensive documentation package including GMP certificate and a technovigilance report covering the past 5 years.
  • Subsequent renewals (from January 2026): reduced documentation; may be granted for up to 10 years.

Renewal applications must be submitted via DIGIPRiS at least 3 months before expiry.

Phase 8 — Post-approval modifications​

Changes to the device, labelling, manufacturer, or MRH must be notified to or approved by COFEPRIS via a modification application through DIGIPRiS. The scope of change determines whether prior approval or a simple notification is required.