Teams searching “RAF Consulting COFEPRIS” or “titular de registro México” are usually looking for an independent Mexico Registration Holder (MRH) — a Mexican legal entity that will sit on the COFEPRIS sanitary registration so a foreign manufacturer does not have to give the license to its first distributor. That is a real, one-country job. RAF Consulting publishes dedicated holder pages for it in Spanish and English. This article names that product fairly, then explains when a multi-country holder subscription from bioaccess® is the better fit.
What RAF Consulting publishes
RAF Consulting is a Mexico regulatory shop with a public titular de registro / Mexico Registration Holder offer. The Spanish page is rafconsulting.net/titular-registro.php; the English twin is rafconsulting.net/eng/registration-holder.php (both checked as indexed holder URLs on 23 August 2026). Public positioning: independent MRH, not a commercial distributor. The shop also publishes dossier work and a tecnovigilancia unit framed against NOM-240. The commercial contrast they themselves use is independent holder versus distributor-as-titular — the same contrast U.S. sponsors already hear from global RA brands.
What those pages do not publish — and this is a finding, not an insult — is a multi-country LATAM holder subscription, government fees and sworn translations inside one annual fee, or a trial-to-commercialization bridge with the same operator. RAF is a Mexico titular. Treat it as one.
Why Mexico needs a titular at all
COFEPRIS issues the sanitary registration in the name of a Mexico-established establishment. The titular del registro carries legal responsibility for the product. A foreign manufacturer that is not constituted in Mexico must appoint someone who is. That someone can be (1) the manufacturer’s own Mexican filial, (2) an independent holder / “empresa estratégica” already notified to COFEPRIS, or (3) a commercial distributor that will also be the titular. Option 3 is still common. It is also how a registration becomes leverage: changing the commercial channel later usually means a cesión de derechos, a new dossier, or both.
COFEPRIS can name multiple distributors and importers on a single registration. That is why an independent titular is useful: the manufacturer keeps the license and adds or drops commercial partners without handing them the asset. See Mexico — COFEPRIS medical device registration and the importer-of-record guide.
Mexico also has an equivalence route (vía abreviada) for devices already approved and marketed by the same manufacturer in a reference country (U.S. FDA, Health Canada, or Japan). A CE mark alone does not qualify. bioaccess® manages Class I–III COFEPRIS work on that pathway and on the standard route. Typical published processing targets (~30 / ~35 / ~60 working days by class; ~30 working days on the equivalence target) are routinely exceeded in practice; COFEPRIS retains full technical discretion. Approval is never guaranteed.
RAF Consulting vs bioaccess®
| Dimension | RAF Consulting | bioaccess® |
|---|---|---|
| Public product | Independent Mexico MRH / titular de registro + dossier + tecnovigilancia | LATAM Launch Subscription: register + hold already-cleared devices |
| Geography published | Mexico / COFEPRIS | 19 LATAM markets; own in-country entities; country pages for Mexico, Brazil, Colombia, Argentina, Chile |
| Who holds the license | RAF as independent titular (their pages) | bioaccess® through its own Mexican entity, for the manufacturer’s benefit |
| Distribution | Positions as not the distributor | Holder is not the commercial distributor; registration is not leverage |
| Gov fees + certified translations | Not published as one included annual bundle | Included in the annual subscription (sworn where required) |
| Trial-to-market | Not a published FIH CRO + holder bridge | Trial-to-Market Bridge 20% for clinical-trial clients of bioaccess® |
The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them through its own in-country entities — sanitary registration, registration holder / importer of record, certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it), and government submission fees, inside one annual subscription per country and device family. Public coverage is described as 19 LATAM markets, with named pathways for ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID, MINSA, ARCSA, DNM/SRS, and DIGEMAPS. The registration is held for the manufacturer’s benefit, with defined transfer provisions in the agreement; it is not leverage. Clinical-trial clients of bioaccess® receive the published Trial-to-Market Bridge (20% off the subscription). Specific rates are under review; contact bioaccess® for a quote. See the LATAM importer-of-record rules for how holder and importer split by country.
When RAF is the right hire
Hire a Mexico-only independent MRH when the commercial plan is Mexico, the manufacturer wants a homegrown COFEPRIS face, and there is no second-country clock. RAF’s public pages are built for that search. Hire bioaccess® when Mexico is the first of several labels — Brazil ANVISA, Colombia INVIMA, Argentina ANMAT, Chile ISP, Peru DIGEMID, and the rest of the published 19-market coverage — and the manufacturer wants one operator, one annual fee shape, and a holder who will not become the commercial channel.
If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.
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