Freyr Solutions publishes a dedicated “medical device registration in LATAM” hub. That page is why this article exists. A manufacturer searching “LATAM device registration” or “Brazil Registration Holder” will see Freyr and bioaccess® in the same cluster. Freyr is a global regulatory-affairs firm with a LATAM device offering. bioaccess® is the LATAM holder subscription. Both can be on an RFP. They should not be scored as the same SKU.
Tone first: Freyr is a legitimate global RA shop. If you need a worldwide dossier machine and you already buy Freyr for other regions, keep them. If you need an in-country titular who includes government fees and certified translations in one annual fee, holds through own entities, and will still be there if the next milestone is a LATAM trial, that is bioaccess®.
What Freyr publishes about LATAM devices
The LATAM registration page is freyrsolutions.com/medical-devices/medical-device-registration-in-latam. It states a “strong presence in Brazil, Mexico, and Colombia.” The medical-device market-access hub lists Brazil (ANVISA), Mexico (COFEPRIS), Argentina (ANMAT), and Colombia (INVIMA). Country microsites exist at freyrsolutions.com.br and freyrsolutions.com.mx. Those are the public geography claims used here. No extra countries are added.
The Brazil Registration Holder page is the sentence that matters for this comparison. Freyr writes that it acts as the BRH — liaison / agent language, “Act as the BRH” — and that it has an extensive partner network across Brazil. Read both halves. “We act as BRH” is a holder claim. “Partner network across Brazil” is a network claim. A manufacturer should ask, in writing, which local CNPJ will be the detentor de registro on this file, and whether that company is Freyr-owned or a partner. Transfers in Brazil require the current holder’s cooperation; Freyr’s own materials warn that changing BRH is not a casual email.
The Mexico language on the public medical-device pages is coordination with the registration holder and the local legal representative. That is not the same sentence as “Freyr is your Mexico Registration Holder.” Treat Mexico as RA coordination unless a signed SOW names Freyr (or a named Freyr Mexico entity) as titular. Argentina is listed on the market-access hub as ANMAT; that is a listed market, not automatically a published AAR-owned-entity claim.
Commercial model, as published: “cost-effective annual support for BRH Service.” That is annual holder support, not an all-in government-fee-plus-certified-translation subscription. “Approved translation” appears as a challenge on Freyr’s LATAM materials, not as an included in-house factory. The marketing KPI “99%+ first-time-right” is a quality statistic. It is not a fee-credit guarantee if the vendor misses a submission date it controls. No Trial-to-Market Bridge (LATAM FIH CRO + commercial registration) is published. Facts from Freyr’s public medical-device pages, retrieved 23 August 2026. No clients or emails added.
BRH is a legal person, not a slide
ANVISA issues the registro or notificação to a detentor de registro. That company is on the hook for post-market obligations and for authorizing importadores (RDC 751/2022; importers can be added without re-registering the device under the rules summarized on the IOR guide). If the detentor is a partner in a network, you have a competent local face and a second contract to unwind later. If the detentor is the vendor’s own Brazilian company, you have one throat to choke and a cleaner transfer covenant — provided the covenant is actually in the agreement.
bioaccess® holds LATAM registrations through its own in-country entities for the manufacturer’s benefit, with defined transfer provisions so the file is not leverage. Brazil is one of the six core markets detailed on the ANVISA country page. The LATAM Launch Subscription puts government submission fees and certified Portuguese (sworn where required) inside the annual fee. Brazil BGMP site audit remains outside any honest flat fee and is billed at vendor cost plus published G&A — that carve-out is on the hub, not hidden.
Freyr vs bioaccess®
| Dimension | Freyr Solutions (public) | bioaccess® |
|---|---|---|
| Product | Global RA / market access; LATAM device-registration hub; annual BRH support | LATAM Launch Subscription: sanitary registration + holder / IOR |
| Public LATAM footprint | “Strong presence” BR / MX / CO; hub lists ANVISA, COFEPRIS, ANMAT, INVIMA | 19-market coverage; hub details BR, CO, MX, AR, CL, PE and names MINSA, ARCSA, DNM, DIGEMAPS |
| Brazil Registration Holder | Freyr acts as BRH and cites a partner network across Brazil — ask which model applies to your CNPJ | Own-entity holder; transfer provisions in the agreement |
| Mexico | Public language: coordination with the registration holder / local legal representative | bioaccess® as independent titular / IOR on the COFEPRIS workstream |
| Bundle | Annual BRH support; gov fees + certified translations not published as one all-in family fee | Government submission fees + certified translations included |
| Translation | Listed as a challenge (“approved translation”), not as included in-house production | In-house; sworn where required; manufacturer owns the translation memory |
| Guarantee language | “99%+ first-time-right” = marketing KPI, not a fee-credit remedy | Submission Guarantee: we credit a portion of that country’s annual fee if we miss the submission workmanship we control (full terms in the proposal) |
| Pricing | Project / line-item plus annual BRH support; no public all-in LATAM subscription | Flat annual subscription per country / device family; rates under review — contact for a quote |
| Trial-to-Market Bridge | Global RA, not a published LATAM FIH CRO | Same partner from LATAM trial to commercial registration |
When Freyr is the better fit
- You want a global RA firm for a worldwide submission calendar, and LATAM is one region on that calendar.
- You specifically want Freyr’s BRH annual-support product and you have confirmed, in writing, whether the detentor is Freyr or a partner.
- You will buy translations and government fees as separate lines and you are comfortable with a first-time-right KPI instead of a fee-credit clause.
- Your live LATAM set is the BR / MX / CO presence (plus ANMAT as listed) and you do not need the rest of the 19-market holder map on day one.
When the LATAM Launch Subscription is the better fit
- The buying criterion is “who is on the certificate,” not “who can coordinate a holder.”
- You want government fees and certified translations inside the annual fee.
- You want a Submission Guarantee that can credit fee, not only a 99%+ statistic.
- You need holder / IOR beyond the four regulators Freyr lists, or you need the multi-importer vs single-IoR map.
- You want the Trial-to-Market Bridge.
Read market access, IOR, Brazil, Mexico, Colombia, Argentina. Compares already live: vs Emergo by UL, vs Qserve.
What to ask Freyr (and any global RA shop) before you sign a BRH
- Name the Brazilian company that will be the detentor. Employee count in São Paulo is not the answer.
- Is that company Freyr-owned or a partner? Who signs the transfer if we leave?
- On Mexico: will Freyr be the titular, or will Freyr coordinate a third-party holder?
- Are ANMAT filings done as AAR, or is Argentina a project-management line?
- Itemize government fees and sworn translations. If they are extra, put them in the comparison total.
- What happens commercially if a first-time-right miss is the vendor’s workmanship? A KPI slide is not a credit.
bioaccess® pricing stays under review — contact for a quote. Do not treat typical-competitor ranges on the hub as a Freyr quote; they are category context, not this firm’s invoice.
FAQ — Freyr LATAM / BRH
Does Freyr register medical devices in LATAM?
Yes, on its dedicated LATAM device-registration page. It claims a strong presence in Brazil, Mexico, and Colombia and lists ANVISA, COFEPRIS, ANMAT, and INVIMA on the market-access hub.
Does Freyr act as Brazil Registration Holder?
The BRH page says Freyr acts as the BRH and also cites a partner network across Brazil. Confirm which model applies to your registration.
Is Freyr the Mexico Registration Holder on the public page?
The public Mexico language reviewed here is coordination with the holder and local legal representative. Do not assume Freyr is the titular until the SOW says so.
Is “99%+ first-time-right” a Submission Guarantee?
No. It is a marketing KPI. bioaccess®’s Submission Guarantee is a workmanship remedy that can credit a portion of that country’s annual fee. Full terms in the proposal. Neither firm can guarantee agency approval.
Is this a smear of Freyr?
No. Freyr is a global RA firm. The distinction is product: annual BRH support and LATAM coordination versus a LATAM-only all-in holder subscription.
Where should a sponsor start?
Sources for competitor facts: freyrsolutions.com medical-device LATAM, market-access, and Brazil Registration Holder pages (plus .br / .mx medical-device microsites), retrieved 23 August 2026. bioaccess® facts: bioaccessla.com/market-access and bioaccessla.com/latam-importer-of-record. No invented clients, emails, statistics, or country lists.
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