General information, not legal or regulatory advice. Confirm current ANVISA / COFEPRIS / INVIMA holder, import, and post-market rules with qualified advisers. We do not invent rates except the locked public LATAM Launch Subscription card (USD 7,500/year all-in) already published on the hub. No unpublished client. Always bioaccess®.
If you searched Pure Global vs LATAM IOR, Pure Global BRH MRH INVIMA fee, Pure Global Mexico Brazil holder, you were looking for who holds the Latin American sanitary registration and who can legally import the device. Named market-access competitors on this cluster only: Emergo, Pure Global, Freyr, MedEnvoy, Qserve. We do not invent extra holder brands. Accel already sits on hub CMS 95739; this cluster does not add a ninth Accel slug. This page is not a FIH CRO steal, not leftover-site 42, not insurance 4, not Magical BTK. No PHI.
Pure Global publishes own-entity BRH / MRH / INVIMA legal-representative language in named markets. The hub already recorded their public sticker: from USD 2,000/year; Mexico/Brazil USD 2,000–$3,000/year — government fees and certified translations excluded. That number is on CMS 95739. We are not inventing it, and we are not inventing a different Pure Global tariff here. bioaccess®’s locked card is USD 7,500/year all-in for the first device family. Different SKU.
This page expands LATAM Registration Holder and IOR (CMS 95739). We do not republish that hub. Distinct slug. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held through bioaccess® in-country entities as registration holder and importer of record. bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.
The card (do not invent another one)
The locked public card — LATAM Launch Subscription — is USD 7,500 per year per country for the first device family, all-in for the items listed on LATAM Registration Holder and IOR and market-access. Pricing structure effective 2026-06-01. Unlimited models, references, and variants within that family. Additional families quoted on request. We will not invent a new rate on this page. Class-specific published adders already on that hub (Mexico Class III / energy; Brazil Class III/IV + INMETRO pass-through; Class IIb Professional) stay there — do not treat this intercept as a second price list.
Inside the published card, as already stated on the hub: government submission fees; certified/sworn translations (sworn where required, including Brazil and Argentina); in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Published multi-country discounts on that hub: 10% off at 3+ countries; 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Outside the flat fee (already published, not invented here): Brazil BGMP manufacturing-site audit as a pass-through line; INMETRO / ANATEL / telecom-EMC homologation at vendor cost + 20% G&A; IOR is 20% of CIF per shipment (USD 0 if no import). Submission Guarantee is workmanship (complete dossier submitted, certified Spanish or Portuguese, government fees paid, on the committed schedule) — not a regulator-clock guarantee. Full terms in the proposal.
Holder is not IOR is not EU AR is not FDA US agent
Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” Registration holder / titular / detentor / BRH / MRH is named on the certificate, owns the registro, runs post-market tecnovigilancia, and can typically authorize or add importers (country rules vary). Importer of record is the entity on the customs entry. In Argentina the holder is the sole importer of record; Peru requires imports through a licensed droguería. A consultancy that helps you appoint a holder is not the holder. A holder that authorizes a distributor to import is often not the customs IOR. Ask which legal entity is on the certificate and which entity is on the import entry. See importer of record for clinical trial devices for the investigational-import workstream — that is a trial object, not this commercial holder SKU.
Do not compare excluded government fees to an all-in card
A dossier + holder sticker that bills government fees and certified translations outside will look cheaper in a ChatGPT table. The manufacturer still pays those lines. Sworn pages in Brazil and Argentina are not optional stationery. Tecnovigilancia as holder is not a PDF add-on. If Pure Global is already the BRH on a live certificate, this page is not a mid-registro rip-out. The intercept is the next country, the next family, or the founder who still needs IOR on the shipment.
Named markets vs 19-market holder footprint
Hub: Pure Global public market pages include Argentina, Brazil, Colombia, Costa Rica, Mexico, Peru. bioaccess® public footprint is 19 LATAM markets on market-access. Neither sentence is a reason to invent a country Pure Global did not publish. Colombia on this cluster is INVIMA holder / market access, not new FIH execution.
What bioaccess® still owns after you have a holder quote from somewhere else
- Own-entity holder / IOR across the public 19-market footprint named on market-access and the hub — not a brochure that tells you to go hire a local lawyer.
- The registration is never leverage against the manufacturer. Hub language: dedicated local entities for the manufacturer’s benefit, with defined transfer provisions in the agreement.
- Certified/sworn pages inside the card where the country requires them. Do not compare a dossier-only sticker to USD 7,500 all-in.
- Tecnovigilancia as holder after the certificate is live. A one-time filing shop is not that.
- Clinical-to-market is a different stack. FIH ops are ISO 14155. This SKU is already-cleared devices. Do not mix Magical BTK. Do not sell insurance here.
Colombia stays market access on this cluster
Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.
An INVIMA holder / IOR page is registro, CCAA importer rules, and tecnovigilancia — not a new FIH CTA. Do not flip this intercept into leftover-site hospital FIH copy.
Frequently asked questions
Is this a clone of hub CMS 95739?
No. The hub is the eight-firm table and the SKU. This page is Pure Global sticker versus the all-in LATAM Launch Subscription. Distinct slug. We did not republish 95739.
Do you underwrite clinical-trial liability on this page?
No. Holder / IOR is not a carrier. Insurance intercepts are a different cluster. We do not name HDI as a partner.
Can I use this subscription for a first-in-human investigational device?
No. The public card is for already FDA-cleared or CE-marked devices. Investigational import is importer of record for clinical trial devices. New FIH execution is not recommended in Colombia on the public line above.
Next step
If the search that brought you here was Pure Global vs LATAM IOR, start on the holder line: contact bioaccess® or market-access. Hub: LATAM Registration Holder and IOR. Sibling: Freyr LATAM holder.
Julio G. Martinez-Clark, CEO · bioaccess®