Last reviewed: August 2026.
USD 7,500 is not a higher fee for the same SKU. It is a different SKU. Their published sticker is dossier + holder. The bioaccess® LATAM Launch Subscription is registration + holder + government fees + sworn pages + tecnovigilancia. Pure Global’s 5 February 2026 PR Newswire release says the model “starts at USD $2,000” and still calls it “all-inclusive.” The same PR excludes government and third-party charges, import handling, certified translations, and marketing materials. Their pricing page lists Mexico and Brazil from $2,000–$3,000/year, government fees billed separately, and certified translations excluded. They mention “post-market support” and never publish a Mexico or Brazil tecnovigilancia PRICE; their 2025 LATAM costs blog excepts “large-scale vigilance” — unpublished / billed later.
USD 7,500 is not a higher fee for the same SKU. It is a different SKU. Their published sticker is dossier + holder. The bioaccess® LATAM Launch Subscription is registration + holder + government fees + sworn pages + tecnovigilancia.
Four lines an RA or QA manager can screenshot. Pure Global cells use only their published words.
| Line | Pure Global published $2,000–$3,000 | bioaccess® LATAM Launch Subscription $7,500 |
|---|---|---|
| Government and third-party charges | Excluded — PR Newswire, 5 February 2026: “Excluded from the fee are government and third-party charges…” Pricing page: government fees billed separately. | Included |
| Certified / sworn translations | Excluded — same PR: certified translations. Pricing page: “excludes certified translations.” | Included (sworn / certified pages) |
| Import handling | Excluded — same PR: import handling. | Included (titular / RH / IOR) |
| Tecnovigilancia / technovigilance (Mexico & Brazil) | Price unpublished. Pricing and news pages mention “post-market support.” Their 2025 LATAM costs blog excepts “large-scale vigilance.” Unpublished / billed later. | Included as holder |
Silent tecnovigilancia: Pure Global mentions “post-market support” and “vigilance” on its pricing and news pages. It never publishes a Mexico or Brazil tecnovigilancia / technovigilance PRICE. Its 2025 LATAM costs blog excepts “large-scale vigilance.” Unpublished / billed later. This page does not invent a Pure Global tecnovigilancia dollar figure.
Pure Global cells use only their published words: PR Newswire, 5 February 2026 (starts at USD $2,000; excludes government and third-party charges, import handling, certified translations, and marketing materials; still says “all-inclusive”); pureglobal.com/services/pricing (Mexico/Brazil from $2,000–$3,000/year; government fees billed separately; excludes certified translations; mentions post-market support with no Mexico/Brazil tecnovigilancia price); and their 2025 LATAM costs blog (excepts “large-scale vigilance”). Compiled 23 August 2026. bioaccess® Market Access Essentials is USD 7,500/year.
Tecnovigilancia is not a PMS add-on. It is how the titleholder keeps the registration legal.
In Mexico, Brazil, and Colombia the local registration holder must run a tecnovigilancia system after the certificate is granted — a named unit, a responsible professional, written procedures, and statutory adverse-event clocks. Mexico now writes that duty into the Ley General de Salud (art. 262 Bis, DOF 15 Jan 2026). The Mexican five-year Informe de Tecnovigilancia is part of registro renewal (NOM-240-SSA1-2012 §6.7.12). Brazil’s detentor do registro must answer ANVISA on AEs, complaints, and field actions (RDC 67/2009 art. 3). Colombia’s fabricantes e importadores must run an institutional program (Res. 4816/2008). If that system fails, the authority can suspend or cancel the registro, seize or freeze product, prohibit use, and — in Colombia for controlled-tech equipment — suspend import and sale (Decreto 4725 art. 26). A device without a live registro cannot legally stay on the market. Without a live registro, or if product is secured / use is prohibited, legal import stops.
As holder means the legal system: Mexico UVT, named professional, SOPs, AE clocks, and the Informe de Tecnovigilancia for prórroga; Brazil’s detentor system plus the NOTIVISA duty; Colombia’s Programa Institucional. Large-scale FSCA and recall sit outside that system — that is the vigilance Pure Global excepts. This page does not invent a Pure Global tecnovigilancia dollar figure.
Their published Mexico/Brazil sticker is $2,000–$3,000 for dossier + holder. They describe “post-market support.” They do not publish a tecnovigilancia price and they except large-scale vigilance. The bioaccess® LATAM Launch Subscription is USD 7,500 per year per country: we are the holder, and we run tecnovigilancia as that holder.
| Metric | bioaccess® | Pure Global |
|---|---|---|
| Service focus | LATAM medical device registration + in-country registration holder / importer of record (LATAM Launch Subscription) | LATAM in-country holder / market-access services with a published annual-fee model; not an FIH CRO |
| Geographic scope | 19 Latin American markets — named regulators include ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID, MINSA, ARCSA, DNM, DIGEMAPS | Public market pages for Argentina, Brazil, Colombia, Costa Rica, Mexico, and Peru. Own entities named for Colombia and Mexico, plus a São Paulo office. Peru, Argentina, and Costa Rica are not treated here as proven own-entity markets. No public ARCSA, MINSA, DNM, DIGEMAPS, or ISP holder pages. |
| Pricing model | LATAM Launch Subscription: USD 7,500 / year per country, first device family — government fees + sworn translations + titular/RH/IOR (import handling) + tecnovigilancia as holder included. | Published sticker starts at USD $2,000 (PR Newswire, 5 February 2026); Mexico/Brazil from $2,000–$3,000/year (pricing page). Same PR still says “all-inclusive” and excludes government and third-party charges, import handling, certified translations, and marketing materials. |
| First device family (low-to-mid risk) | USD 7,500 / year — Market Access Essentials (government fees, sworn translations, titular/RH/IOR, tecnovigilancia as holder) | Sticker: from USD $2,000/yr (PR, 5 February 2026); Mexico/Brazil from $2,000–$3,000/year. Government fees and certified translations billed outside that sticker per Pure Global's own pages. |
| Additional device family (same country) | USD 3,500 / 4,500 / 5,500 (unlimited models/references within a family included) | Not published as an all-in family quote on the pages reviewed |
| Registration holder / importer of record | bioaccess® holds registrations through our own in-country legal entities across 19 LATAM markets; held for your benefit with defined transfer provisions — the holder is never leverage | Acts as BRH, MRH, and INVIMA Legal Representative, plus CCAA importer in Colombia, through Pure LATAM Colombia SAS, Pure Latam Mexico S. de R.L. de C.V., and a São Paulo office. Local-partner language appears on the Peru page. |
| Timeline commitment | bioaccess® Submission Guarantee: complete dossier submitted, in certified Spanish or Portuguese, with government fees paid on the committed schedule, or we credit a portion of that country's annual fee (full terms in proposal) | No public Submission Guarantee equivalent (fee-credit for submission workmanship) on the pages reviewed |
| Best-fit sponsor profile | FDA-cleared or CE-marked device teams entering LATAM who want one flat annual fee and one accountable partner per country | Sponsors who want a published starting holder fee in a subset of LATAM markets and will budget government fees and translations separately |
| Tecnovigilancia / technovigilance (Mexico & Brazil) | Included as holder on the USD 7,500/year Essentials card | Mentions “post-market support” and “vigilance.” Never publishes a Mexico or Brazil tecnovigilancia PRICE. 2025 LATAM costs blog excepts “large-scale vigilance.” Unpublished / billed later. |
| Trial-to-Market Bridge | 20% off the Launch Subscription for existing clinical-trial clients | Not an FIH CRO; no public Trial-to-Market equivalent |
Holder, entity, and fee facts about Pure Global are taken from Pure Global public pages and a PR Newswire release dated 5 February 2026 (compiled 23 August 2026). The USD $2,000 starting fee and Mexico/Brazil $2,000–$3,000/year range are published figures. Government fees, certified translations, import handling, and marketing materials sit outside that sticker per the same PR. This page does not invent a Pure Global tecnovigilancia dollar figure. bioaccess® Market Access Essentials is USD 7,500 per year per country for the first device family. Additional families: USD 3,500 / 4,500 / 5,500. This page does not claim a named-sponsor registration.
More so than to a global full-lifecycle RA consultancy. The commercial contrast is the SKU, not a higher price for the same work. Their published sticker starts at USD $2,000 (Mexico/Brazil $2,000–$3,000/year). The same 5 February 2026 PR still says “all-inclusive” and then excludes government fees, certified translations, import handling, and marketing materials. bioaccess® LATAM Launch Subscription is USD 7,500 / year: registration + holder + government + sworn pages + tecnovigilancia as holder.
Their own PR uses that word and then lists carve-outs. The 5 February 2026 PR Newswire release says the model starts at USD $2,000 and still calls it “all-inclusive.” The same PR excludes government and third-party charges, import handling, certified translations, and marketing materials. Their pricing page lists Mexico and Brazil from $2,000–$3,000/year, government fees billed separately, and certified translations excluded.
No. Their pricing and news pages mention “post-market support” and “vigilance.” They never publish a Mexico or Brazil tecnovigilancia / technovigilance PRICE. Their 2025 LATAM costs blog excepts “large-scale vigilance.” Unpublished / billed later. bioaccess® includes tecnovigilancia as holder on the USD 7,500/year Essentials card.
In Mexico, Brazil, and Colombia the local registration holder must run a tecnovigilancia system after the certificate is granted — a named unit, a responsible professional, written procedures, and statutory AE clocks (LGS art. 262 Bis; NOM-240-SSA1-2012 §6.7.12; RDC 67/2009 art. 3; Res. 4816/2008). If that system fails, the authority can suspend or cancel the registro, seize or freeze product, and prohibit use — and in Colombia, for controlled-tech equipment, suspend import and sale (Decreto 4725 art. 26). A device without a live registro cannot legally stay on the market. Without a live registro, or if product is secured / use is prohibited, legal import stops.
The legal system: Mexico UVT, named professional, SOPs, AE clocks, and the Informe de Tecnovigilancia for prórroga; Brazil’s detentor system plus the NOTIVISA duty; Colombia’s Programa Institucional. Large-scale FSCA and recall are the vigilance Pure Global excepts. They describe “post-market support” and do not publish a tecnovigilancia price. The bioaccess® LATAM Launch Subscription is USD 7,500 per year per country because we are the holder and we run that system.
Yes, if the split is practical. Sponsors who already have Pure Global as holder in one published market sometimes use bioaccess® for additional LATAM markets or for an all-inclusive Launch Subscription that includes government fees and certified translations.
Choose Pure Global when their published sticker (from USD $2,000/yr; Mexico/Brazil from $2,000–$3,000/year) matches your scope and you will budget government fees, certified translations, import handling, marketing materials, and any later tecnovigilancia separately. Choose bioaccess® when you want those items inside one annual fee of USD 7,500 / year Market Access Essentials.
LATAM Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Colombia (INVIMA) · Brazil (ANVISA) · Mexico (COFEPRIS) · Argentina (ANMAT) · Chile (ISP)