Last reviewed: August 2026.
Pure Global is the closest publicly described analogue to a LATAM holder-subscription shop: a flat annual fee starting at USD $2,000/yr (Mexico page and PR Newswire, 5 February 2026), with own entities in Colombia (Pure LATAM Colombia SAS, Bogotá) and Mexico (Pure Latam Mexico S. de R.L. de C.V.) and a São Paulo office. They publish market pages for Argentina, Brazil, Colombia, Costa Rica, Mexico, and Peru, and they act as Brazilian Registration Holder (BRH), Mexican Registration Holder (MRH), and INVIMA Legal Representative plus CCAA importer in Colombia. Per the same PR, government fees, certified translations, and marketing materials sit outside that annual fee. Peru's page describes a local partner and acting as holder — this page does not treat Peru, Argentina, or Costa Rica as proven own-entity markets. There is no public ARCSA, MINSA, DNM, DIGEMAPS, or ISP holder page, no public Submission Guarantee equivalent, and Pure Global is not an FIH CRO. bioaccess® is purpose-built for the LATAM Launch Subscription across 19 markets: own in-country holder/IOR, government fees and in-house certified translations in one annual fee (pricing under review — contact for a quote), a bioaccess® Submission Guarantee (workmanship), and a Trial-to-Market Bridge (20% for trial clients).
| 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: single all-inclusive flat annual fee per country/family (government submission fees + in-house certified/sworn translations + in-country holder/IOR + regulatory liaison). Pricing under review — contact for a quote. | Published starting annual fee from USD $2,000/yr (Mexico page and PR Newswire, 5 February 2026). Same PR: government fees, certified translations, and marketing materials sit outside that fee. |
| First device family (low-to-mid risk) | Custom quote — all-inclusive (pricing under review) | Starting public figure USD $2,000/yr; government fees and certified translations billed outside that figure per Pure Global's PR |
| Additional device family (same country) | Quoted on request (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 |
| 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/yr starting fee is a published figure; government fees, certified translations, and marketing materials sit outside that fee per the same PR. Peru, Argentina, and Costa Rica are not treated here as proven own-entity markets. bioaccess® pricing is under review — contact for a quote. This page does not claim a named-sponsor registration.
More so than to a global full-lifecycle RA consultancy. Pure Global publishes a LATAM annual-fee holder model and own entities in Colombia and Mexico, with a São Paulo office and market pages for Argentina, Brazil, Colombia, Costa Rica, Mexico, and Peru. bioaccess® is purpose-built for the LATAM Launch Subscription across 19 markets: own in-country holder/IOR, government fees and in-house certified translations in one annual fee (pricing under review — contact for a quote), a bioaccess® Submission Guarantee (submission workmanship — full terms in proposal), and a Trial-to-Market Bridge for trial clients. If a published starting holder fee in a few markets — with government fees and translations outside that fee — matches your scope, Pure Global is a reasonable fit. If you want those items inside one annual fee, plus 19-market own-entity coverage and a workmanship fee-credit, bioaccess® is purpose-built for it.
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. Pairing a global RA shop with bioaccess® for LATAM is also a common pattern.
Choose Pure Global when a published starting annual holder fee (from USD $2,000/yr) in the markets where they publish own entities matches your scope, and you will budget government fees, certified translations, and marketing materials separately. Choose bioaccess® when LATAM registration in one or more of 19 markets is the near-term milestone and you want those items inside one annual fee, with a written Submission Guarantee (workmanship).
LATAM Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Colombia (INVIMA) · Brazil (ANVISA) · Mexico (COFEPRIS) · Argentina (ANMAT) · Chile (ISP)