New Pathway Overview
COFEPRIS published the formal regulatory framework for its De Novo equivalent pathway — titled Vía de Clasificación para Dispositivos Novedosos (VCDN) — in the Diario Oficial de la Federación on 28 July 2026. The pathway is available to Class III device manufacturers that can demonstrate no valid predicate exists in the Mexican device register and that their device addresses an unmet clinical need.
Eligibility and Submission Requirements
Applicants must submit a Pre-Submission request to COFEPRIS at least 60 working days before the formal VCDN application, during which the agency confirms predicate absence and agrees on the performance testing protocol. The formal submission requires a complete technical dossier, clinical evidence from at least one study conducted in Mexico or a recognised jurisdiction, and a proposed Special Controls framework.
Review Timeline Commitment
COFEPRIS has committed to a 90 working-day target review time for complete VCDN applications. An interactive review process allows a single Request for Information to be issued during the review period. COFEPRIS has allocated three dedicated reviewers to the VCDN pathway supported by external expert consultants for novel technology areas.
Implications for Market Access
Industry groups have welcomed the VCDN as a significant step towards reducing the market access gap for innovative devices in Mexico, which historically trailed US and EU approval timelines by 24–36 months for Class III products. The pathway is expected to reduce this gap to under 12 months for manufacturers with well-prepared dossiers.