Abbreviated Registration Pathway for Devices Approved by Reference Authorities
COFEPRIS introduced an abbreviated registration pathway for medical devices that already hold marketing authorisation from a recognised reference regulatory authority — including the FDA (510(k)/PMA), CE mark under EU MDR/IVDR, Health Canada, TGA (Australia), or ANVISA (Brazil). Eligible devices can leverage the reference approval as the primary basis for their Mexican Sanitary Registration (Registro Sanitario), substantially reducing technical documentation requirements and review timelines.
🔖 Status: in-force
Manufacturers with existing approvals from reference countries should assess whether the abbreviated route is available for their Mexican submission. Key eligibility factors include device class, the specific reference authority, and whether the device is already legally marketed in the reference market. The abbreviated pathway does not eliminate all local requirements — Spanish labelling (per NOM-137-SSA1-2025), local representative obligations, and post-market commitments remain in force. Consult your regulatory affairs team or a Mexico-based RA specialist to confirm eligibility before selecting this route.
View official source (COFEPRIS) ↗