Equivalency (Abbreviated) Route
The Equivalency Route (also called the Abbreviated Route or ruta de equivalencia) allows manufacturers with existing approvals from recognised foreign authorities to obtain Mexican sanitary registration with a significantly reduced dossier and faster review.
Regulatory basis
The Equivalency Route was formalised and substantially expanded by the Acuerdo published in the Diario Oficial de la Federación on June 11, 2025, and became operational September 1, 2025. COFEPRIS now accepts approvals from all IMDRF member authorities and all MDSAP-participating authorities.
Recognised Reference Regulatory Authorities (RRAs)
COFEPRIS recognises approvals from:
| Authority | Jurisdiction | Notes |
|---|---|---|
| FDA (510k, De Novo, PMA) | USA | Full recognition |
| Health Canada | Canada | Class II–IV only |
| European Union (CE Mark under MDR/IVDR) | EU | Full recognition |
| TGA | Australia | Full recognition |
| PMDA | Japan | Full recognition |
| Swissmedic | Switzerland | Full recognition |
| All other IMDRF members | Various | Per June 2025 Acuerdo |
| All MDSAP-participating authorities | Various | Per June 2025 Acuerdo |
Eligibility requirements
To use the Equivalency Route, the device submitted to COFEPRIS must be identical to the version approved by the reference authority in:
- Formulation and materials
- Manufacturing process
- Intended use
- Technical specifications and configuration
Even minor differences may disqualify the device from the equivalency route, requiring a standard submission.
Abbreviated dossier — what to submit
| Document | Notes |
|---|---|
| Certificate of Free Sale (CFS) | From the reference authority's home country |
| Copy of foreign approval decision | 510(k) clearance, CE certificate, TGA licence, etc. |
| Abbreviated technical summary | Device description, intended use, reference to foreign approval |
| Spanish-language labelling (draft) | Compliant with NOM-137-SSA1-2008 |
| MRH appointment documentation | Power of attorney |
| Proof of fee payment |
Timeline
COFEPRIS targets a review period of 30 working days for equivalency route applications. In practice, actual timelines may be longer depending on COFEPRIS workload and any requests for additional information.
The equivalency route does not permit use of a third-party pre-approving agency. Applications go directly to COFEPRIS.
Limitations and practical considerations
- The device must be identical — even labelling changes can cause issues; a bilingual Spanish label is typically required.
- COFEPRIS may still request supplementary information.
- The third-party pre-review option available for the standard route is not available for equivalency submissions.
- For Health Canada-based equivalency, only Class II and above qualify.