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; bioaccess® pricing is the two-part model on the rate card. No unpublished client.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 the LATAM Registration Holder and IOR hub; this cluster does not add a ninth Accel page. 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 LATAM Registration Holder and IOR. We are not inventing it, and we are not inventing a different Pure Global tariff here. bioaccess® pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card). Different SKU.
This page expands LATAM Registration Holder and IOR. We do not republish that hub. distinct page. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held by bioaccess® as registration holder and importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner). bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.
The card (do not invent another one)
bioaccess® pricing is two-part: a one-time registration fee per country (by device class), then a lower annual holder fee from year 2. One-time registration fee per country by class (Class I/II, IIa/IIb, III/IV): Mexico $5,000 / $8,000 / $13,250; Colombia $4,000 / $6,250 / $9,000; Brazil $6,750 / $11,500 / $22,250; Peru $4,250 / $6,500 / $10,500; Argentina $4,500 / $6,500 / $12,000. Annual holder fee from year 2: Mexico $4,500; Colombia $3,900 (our own Colombian entity holds the registration); Brazil $6,000 (Class I/II) or $7,500 (Class III/IV); Peru $4,200; Argentina $4,200. USD, excluding VAT and local taxes. Chile is quoted case by case. Prices are valid for agreements signed by 31 March 2027; this is information only, not an offer. Full table on the rate card.
What the holder does: in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Brazil BGMP manufacturing-site audit and INMETRO / ANATEL / telecom-EMC homologation are separate lines. Import shipments are quoted separately, per shipment (no charge if there is no import). 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.
Compare like with like: check what each quote includes
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 page is the next country, the next family, or the founder who still needs IOR on the shipment.
Named markets vs multi-country holder footprint
Hub: Pure Global public market pages include Argentina, Brazil, Colombia, Costa Rica, Mexico, Peru. bioaccess® publishes pricing for Mexico, Colombia, Brazil, Peru and Argentina 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; separately, bioaccess® runs first-in-human studies in Colombia now.
What bioaccess® still owns after you have a holder quote from somewhere else
- Registration holder / IOR across the public LATAM 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 where the country requires them. Check who produces them before you compare quotes.
- 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.
Colombia: first-in-human studies and market access
Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes 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.
Frequently asked questions
Is this the same as the LATAM Registration Holder and IOR hub?
No. The hub is the eight-firm table. This page is Pure Global versus bioaccess® market access, a distinct page.
Do you underwrite clinical-trial liability on this page?
No. Holder / IOR is not a carrier. Insurance pages are a different cluster. We do not name HDI as a partner.
Can I use this holder service 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. bioaccess® runs first-in-human studies in Colombia now.
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®