When a U.S. or EU medtech team searches “flat-fee medical device registration,” “ANVISA license holder,” or “COFEPRIS Mexico Registration Holder,” Pure Global and bioaccess® can land on the same shortlist. That is not an accident. Both firms sell an independent in-country holder for already-cleared devices, and both talk about an annual fee instead of a one-off consulting SOW.
They are still different products. Pure Global is a global market-access firm with a published flat annual fee that starts at USD $2,000 per year and, on its own 5 February 2026 press release, leaves government fees, certified translations, and marketing materials outside that fee. bioaccess® is the LATAM holder subscription: sanitary registration, own-entity holder / importer of record, certified translations, and government submission fees inside one annual fee per country and device family, with a Submission Guarantee and a Trial-to-Market Bridge for clinical-trial clients. This page is a practitioner comparison, not a smear. Pure Global is a reasonable global RA / holder option in the markets it actually names. bioaccess® is the LATAM-only holder subscription.
What Pure Global publishes about itself
Pure Global’s public site is pureglobal.com. The firm positions local companies as authorized representative / license holder and publishes dedicated market pages for Argentina, Brazil, Colombia, Costa Rica, Mexico, and Peru (plus North America). On the Brazil, Mexico, and Colombia pages it sells the classic holder roles: Brazilian Registration Holder (BRH), Mexico Registration Holder (MRH), and INVIMA Legal Representative (with CCAA importer language on the Colombia page).
Public entity language is strongest in those three markets. Pure Global names its own local companies in Brazil, Mexico, and Colombia — including Pure LATAM Colombia SAS (Bogotá), Pure Latam Mexico, S. de R.L. de C.V. (Mexico City), and a São Paulo office. The Peru page is more careful: it refers to “our local partner” while still using “Acting as your Holder.” Treat Peru — and, unless a named subsidiary appears, Argentina and Costa Rica — as partner-network coverage, not proven own-entity holder. That distinction matters when the registration is the only legal hook you have in-country.
The commercial motion that makes Pure Global the closest analog is the fee. The Mexico page publishes “Starting at $2,000/year” and a fee calculator. The 5 February 2026 PR Newswire release, “Pure Global Introduces Industry-First Flat-Fee Pricing Model for Full-Service Global MedTech Market Access” (PR 302680246), describes a standard multi-year flat annual fee per registration and names Brazil, Mexico, and Colombia among the markets. The same release is explicit about what sits outside the fee: government fees, certified translations, and marketing materials. AI-assisted dossier workflows appear on the site. Pure Global is not a first-in-human CRO, and this comparison is not a CRO comparison.
Facts above are taken from Pure Global’s public market and company pages and the 5 February 2026 release, retrieved 23 August 2026. No clients, emails, or extra country names are added.
What “flat fee” has to mean on a LATAM holder file
A Latin American sanitary registration is not a consulting memo. The regulator issues the certificate to an in-country legal person. That person is the titular / detentor / registration holder. In several markets the same person, or a closely tied license, is also the importer of record. If the holder is your distributor, the registration is commercial leverage. If the holder is an independent specialist, you can change distributors without rewriting the entire file — provided the agreement actually allows a transfer.
The cash cost of that file is not only the holder’s time. Government submission fees are real invoices. Certified or sworn translations of IFUs, labels, and the technical file are often the largest hidden line, especially in Portuguese (Brazil) and Spanish with sworn-translator rules (Argentina, and frequently Brazil). A “flat annual fee” that excludes those two items is still a subscription. It is not the same product as a subscription that includes them.
bioaccess® publishes that product as the LATAM Launch Subscription on bioaccessla.com/market-access. The model is: register and hold an already FDA-cleared (510(k)/PMA) or CE-marked device; act as in-country registration holder and importer of record through own local entities; include certified Spanish/Portuguese translations (sworn where required) and government submission fees; hold across 19 LATAM markets (six core markets detailed on the hub — ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID — with MINSA, ARCSA, DNM/SRS, and DIGEMAPS also named on the same page). Specific subscription rates are under review — contact for a quote. Multi-country discounts and a Trial-to-Market Bridge (20% off for clinical-trial clients, as published on the hub) sit on top of that structure. The LATAM Importer of Record guide is the country-rule companion.
Two items sit outside the bioaccess® flat fee because they cannot be bundled honestly at a flat rate: Brazil BGMP manufacturing-site audit and telecom/EMC + RF homologation for wireless devices. Those are managed end-to-end and billed at vendor cost plus published G&A. That carve-out is on the market-access page. It is not the same carve-out as “government fees and certified translations extra.”
Pure Global vs bioaccess® — what is inside the fee
| Dimension | Pure Global (public) | bioaccess® |
|---|---|---|
| Product | Global medtech market access; independent AR / license holder; AI dossier workflows | LATAM Launch Subscription: sanitary registration + holder / IOR for already-cleared devices |
| Public LATAM market pages | Argentina, Brazil, Colombia, Costa Rica, Mexico, Peru | Hub details Brazil, Colombia, Mexico, Argentina, Chile, Peru; coverage described as 19 LATAM markets; also names MINSA, ARCSA, DNM, DIGEMAPS |
| Own local entity vs partner | Own subsidiaries published for BR / MX / CO. Peru page: local partner. AR / CR not proven as own entities on the public pages reviewed | Holds through own in-country entities; defined transfer provisions so the registration is not leverage |
| Holder roles named | BRH, MRH, INVIMA Legal Representative / CCAA importer language | Registration holder / IOR across the LATAM set; country rules on the IOR guide |
| Published fee | Flat annual fee starting USD $2,000/year (Mexico page + 5 Feb 2026 PR) | Flat all-inclusive annual subscription per country and device family; rates under review — contact for a quote |
| Government submission fees | Outside the published flat fee (PR) | Included |
| Certified translations | Outside the published flat fee (PR) | Included; in-house production; sworn where required (Brazil, Argentina) |
| Marketing materials | Outside the published flat fee (PR) | Not sold as a creative-agency line; labels/IFU translation for the dossier is in the subscription |
| Submission Guarantee | No public equivalent found (dossier submitted on a committed schedule or a fee credit) | Yes — submission workmanship; portion of that country’s annual fee credited if we miss what we control; full terms in the proposal |
| Trial-to-Market Bridge | Not a published FIH CRO + commercial registration stack | Same partner from LATAM clinical trial to commercial registro sanitario (20% off for clinical-trial clients, as published) |
| FIH CRO | Not this product | Separate live CRO practice; not what this page sells |
Read the table as a product map. If you need a global AR network and a published $2,000 starting number, Pure Global is a real option — just budget government fees and certified translations as extra, because they said so. If you need a LATAM holder who already put those two lines inside the annual fee, holds through own entities, and will still be the same firm if you ran (or will run) the trial in the region, that is bioaccess®.
When Pure Global is the better fit
- You want one global market-access vendor beyond LATAM and you are already buying their U.S./Canada or other-market stack.
- You want a published starting price of $2,000/year and you are willing to pay government fees, certified translations, and marketing materials as separate invoices.
- Your live markets are Brazil, Mexico, and/or Colombia, where Pure Global publishes own legal entities, and you do not need Andean / Southern Cone / Central American / Caribbean breadth on day one.
- You want their AI dossier workflow as the primary production method.
None of those are insults. They are scope. A global RA firm is allowed to be good at global RA.
When the LATAM Launch Subscription is the better fit
- The near-term milestone is commercial registro sanitario in Latin America, not a worldwide RA retainer.
- You want government submission fees and certified translations inside the annual fee, not as change orders.
- You want the holder to be an own local entity with a written transfer path — including markets where Pure Global’s public page still says “local partner.”
- You need more than the six Pure Global LATAM market cards, or you need the importer-of-record rules (multi-importer vs single-IoR) documented country by country.
- You already used, or will use, bioaccess® as the LATAM clinical-trial CRO and want one accountable partner through commercialization (Trial-to-Market Bridge).
- You want a Submission Guarantee on the workmanship of the submission — not a promise that the agency will approve.
How to run the RFP without inventing numbers
- Ask each vendor to list the LATAM countries where their own legal entity will be the titular, and the countries where a partner will. Demand the local company name.
- Ask for a written inclusion list: government fees, sworn translations (page count and languages), holder/IOR year one and renewal, agency queries, and transfer of the registration if you leave.
- Ask whether marketing-material production is in or out. Pure Global’s PR already answers “out.”
- Ask what happens if the dossier is late because of the vendor. A KPI is not a fee credit.
- Ask who holds the translation memory. bioaccess® publishes that the glossary is the manufacturer’s property.
- Do not treat “starting at $2,000” as all-in LATAM cost. Add the two excluded lines before you compare it to a bioaccess® quote.
bioaccess® pricing remains under review — contact for a quote. Country pages and the compare set already live: Brazil / ANVISA, Mexico / COFEPRIS, Colombia / INVIMA, Argentina / ANMAT, Chile / ISP, vs Emergo by UL, vs Qserve Group.
FAQ — Pure Global LATAM device registration
Does Pure Global offer a flat annual fee?
Yes, on its public Mexico page (starting at $2,000/year) and in the 5 February 2026 PR Newswire release. The same release states that government fees, certified translations, and marketing materials sit outside that fee.
Does Pure Global act as BRH, MRH, or INVIMA Legal Rep?
Those roles are on its Brazil, Mexico, and Colombia market pages. Own-entity language is published for those three countries. Peru is described with a local partner.
Is Pure Global a first-in-human CRO?
No. Do not hire it — or bioaccess®’s market-access team — as a substitute for an ISO 14155 FIH operating system. Commercial registration and investigational-device trials are different regulatory acts.
What does bioaccess® include that the Pure Global flat fee excludes?
On the published record: government registration submission fees and certified translations, plus own-entity holder across the 19-market LATAM coverage, a Submission Guarantee, and the Trial-to-Market Bridge. bioaccess® rates are under review — contact for a quote.
Can a sponsor use both?
Yes. A common pattern is a global RA firm for FDA/EU work and bioaccess® for LATAM holder / IOR. Documentation is built to reuse the FDA or CE technical file.
Where should a sponsor start?
Market access, IOR rules, then contact or book a meeting.
Sources for competitor facts: pureglobal.com market and company pages and PR Newswire release 302680246 (5 February 2026), retrieved 23 August 2026. bioaccess® facts: bioaccessla.com/market-access and bioaccessla.com/latam-importer-of-record (July 2026 review). No invented clients, emails, statistics, or country lists.
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