COFEPRIS lets a private reviewer clear the file first

This blog has already covered how a third party can review a 510(k) while FDA still decides it. Mexico's COFEPRIS — the Comisión Federal para la Protección contra Riesgos Sanitarios — runs a version of the same split, built into the registration process itself rather than layered onto one submission type: a manufacturer can send a device dossier straight to the agency, or pay a private reviewer to clear it first. Either way, the Registro Sanitario that comes out the other end is COFEPRIS's own decision, not the private reviewer's.

Class sets the evidence; either route can carry it

COFEPRIS classifies devices into three tiers under the Reglamento de Insumos para la Salud — Class I devices well established in medical practice, Class II devices whose materials or use introduce more variability, and Class III devices that are new, recently accepted, or remain inside the body — and review timelines lengthen with class on either route. The classification question and the reviewer question are independent: a Class III device doesn't get routed to a different kind of scrutiny because of its class, it gets routed to whichever of the two review paths the manufacturer chose, carrying whatever evidence that class already requires.

A Tercero Autorizado issues an opinion, not an approval

A Tercero Autorizado — a private entity COFEPRIS and the Secretaría de Salud have authorized to pre-review a dossier, sometimes referred to as a Unidad de Predictamen — can evaluate a device file against the same requirements COFEPRIS would apply directly, and issue a dictamen técnico, a favorable technical opinion, once the file meets them. That opinion travels with the submission when it reaches COFEPRIS, and files carrying one have historically moved through the agency faster than files arriving without it. What the Tercero Autorizado cannot do is grant the registration itself — the dictamen is an input to COFEPRIS's decision, not a substitute for it, and COFEPRIS keeps the authority to disagree with an opinion a private reviewer already issued.

The choice is the manufacturer's, and it's a real trade

Nothing requires a manufacturer to use a Tercero Autorizado; direct submission to COFEPRIS remains available for every class, and a file that goes that route is reviewed against the same substantive standard, just without a private opinion attached to it first. The trade is speed against cost: a Tercero Autorizado charges its own fee on top of COFEPRIS's, and a manufacturer choosing between the two routes is choosing whether that fee is worth the difference in how quickly a complete, correct file tends to clear the agency once it arrives. A submission plan that treats the Tercero Autorizado route as mandatory, or as a way to avoid COFEPRIS scrutiny altogether, has misread which parts of the process it actually changes.

The Titular still has to be someone COFEPRIS can reach

Either route assumes a registration holder — a Titular — with an establishment registered in Mexico, since COFEPRIS doesn't issue a Registro Sanitario to an entity it has no domestic footprint to inspect or serve notice on. A foreign manufacturer without a Mexican establishment typically engages a Mexican firm to act as that Titular, and separately names a Responsable Sanitario, the individual who answers to COFEPRIS for the registered establishment's regulatory and quality compliance day to day. Neither role is the Tercero Autorizado, and confusing the two is an easy mistake: one prepares and stands behind the technical dossier before it's filed, the other is the ongoing point of contact once the registration exists.

Registration terms just changed underneath both routes

A Registro Sanitario, however it was reviewed, is valid for five years from first issuance. What runs on top of that changed in 2026: under amendments to the Ley General de Salud, renewals — the first one and every one after it — are now granted for ten-year terms rather than matching the original five-year period. A registration tracker still assuming every renewal cycle matches the original grant is carrying a five-year assumption a 2026 amendment already replaced for the renewal side of the clock.

Where this meets the file

A Mexico registration tracker needs the review route recorded as its own field — direct COFEPRIS submission or a named Tercero Autorizado — kept apart from the registration's own term, since a device's renewal date no longer follows a single fixed interval once it passes its first cycle. A cross-border registration tracker built to carry that distinction, alongside the launch catalog's other device-registration templates, is previewed there now. If your program has run a file through a Tercero Autorizado and found a gap this one misses, the shelf takes that correction directly.