bioaccess® is the only partner in Latin America that runs your first-in-human (FIH) clinical trial and then registers and holds your device across the region. The LATAM Launch Subscription — USD 7,500 per year per country for the first device family — bundles sanitary registration, in-country registration holder and importer of record, certified translations, government fees, and tecnovigilancia. Coverage across 19 LATAM markets.
Your clinical data was generated by our teams, in our region, under our quality systems. When the same partner writes the dossier, holds the registration, and runs tecnovigilancia, nothing is lost in handoff — no re-explaining the device to a new vendor, no re-translating the technical file, no outside firm learning your risk profile from zero.
Trial-to-Market Bridge: clinical-trial clients save 20% on the LATAM Launch Subscription. If we ran your first-in-human study, your registration starts with the team that already knows your device.
Some regulatory firms argue that regulatory affairs should not be a side offering inside a CRO. We agree — which is why market access at bioaccess® is a dedicated practice with its own regulatory-affairs team, its own in-country legal entities, and its own track record: 25+ registrations completed, 25+ active registrations held.
The difference is what sits next to that team: the clinical operation that generated your data. Our regulatory writers work from the study they watched happen — the investigators, the protocol deviations, the safety narrative — not from a dossier handed over a wall. That is not a side offering. It is the shortest path from first patient to commercial sale.
Every LATAM registration must be tied to an in-country legal entity. bioaccess® holds registrations through its own dedicated local entities — packaged as named products, one per market:
| Product | Market | Includes |
|---|---|---|
| bioaccess® BRH | Brazil (ANVISA) | Registration holder, importer coordination, tecnovigilancia (RDC 67/2009) |
| bioaccess® MRH | Mexico (COFEPRIS) | Registration holder, tecnovigilancia (LGS art. 262 Bis; NOM-240) |
| bioaccess® Colombia Holder | Colombia (INVIMA) | Registration holder, tecnovigilancia (Res. 4816/2008) |
| bioaccess® Argentina Holder | Argentina (ANMAT) | Registration holder, sole importer of record |
| bioaccess® Chile Holder | Chile (ISP) | Registration holder, import pathway |
| bioaccess® Peru Holder | Peru (DIGEMID) | Registration holder via licensed droguería pathway |
Every holder product carries defined transfer provisions in your agreement: if you ever change partners or establish your own entity, the registration transfers on a contractual timeline. Your registration is never leverage against you.
Coverage across 19 LATAM markets; devices registered in 5+ to date.
bioaccess® track record as of September 2026; figures self-reported.
U.S. digital-health cardiac-monitoring company — multi-country LATAM registration. A U.S. cardiac-monitoring (ECG) device company engaged bioaccess® to register its device families across Argentina and Colombia — with bioaccess® serving as in-country registration holder / importer of record and delivering certified Spanish translations of IFUs, labels, and technical files in-house. Scope description only; client has not consented to be named, and no approval, outcome, or dispute is implied.
Brazil's ANVISA is the largest regulatory agency in Latin America, covering a 210M+ patient population. bioaccess® manages Class I–IV device registration through ANVISA's regulatory pathways. Class I & II enter via notificação (effectively immediate on a valid submission); Class III & IV require registro subject to ANVISA's statutory maximum review periods of up to ~250 days (equipment), ~320 days (materials), and ~365 days (IVDs) — observed times are often shorter.
Colombia's INVIMA sanitary registration follows Decreto 4725/2005: Class I and IIa devices receive registro sanitario automático (expedited issuance, verified post-hoc), while Class IIb and III undergo full prior review on the order of ~90 business days. bioaccess® has 15+ years of INVIMA experience.
Mexico's COFEPRIS offers an equivalence route (vía abreviada) for devices already approved and marketed by the same manufacturer in a reference country (U.S. FDA, Health Canada, or Japan); its ~30-working-day figure is a processing target routinely exceeded in practice, and COFEPRIS retains full technical discretion — approval is never guaranteed. Standard (non-equivalence) response times run roughly ~30 (Class I), ~35 (Class II), and ~60 (Class III) working days. A CE mark alone does not qualify for the equivalence route. bioaccess® manages Class I–III registrations.
Argentina's ANMAT regulates medical devices under a risk-based classification (Classes I–IV) under Disposición 2318/2002. Lower-risk classes file via a sworn declaration (declaración jurada) through the ANMAT HELENA electronic platform and register relatively quickly; higher-risk classes undergo substantive review taking several months. These are experience-based estimates, not a statutory cap.
Chile's ISP (Instituto de Salud Pública) regulates medical device registration and import. bioaccess® confirms the registration pathway and timeline at proposal stage and manages the ISP process end to end. Typical timelines run 30–90 days (experience-based).
Peru's DIGEMID (Dirección General de Medicamentos, Insumos y Drogas) requires sanitary registration for imported medical devices, with imports flowing through a licensed droguería. bioaccess® manages DIGEMID registration and the import pathway end to end.
Market Access Essentials / LATAM Launch Subscription is USD 7,500 per year per country for the first device family — all models, references, and variants within that family, as defined in your agreement. Additional families: USD 3,500 (low–mid, any country); USD 4,500 (Class III / high-risk Mexico); USD 5,500 (Class III / high-risk Brazil). See the LATAM Launch rate card.
What many competitors invoice separately after the contract is signed — translations, government fees, registered agents, regulatory liaison — is already included in the bioaccess® USD 7,500 annual subscription:
Why it can be included: translations are typically the largest hidden cost in LATAM device registration. bioaccess® brings translation production in-house on a secure platform with full audit trail and human review by its regulatory team — so translations are not outsourced to a third-party language vendor or marked up. The translation memory and bilingual glossary we build for your dossier are your property.
The bioaccess® structure bundles government submission fees, certified translations, the in-country registered agent, the regulatory liaison, and tecnovigilancia as holder into one flat annual subscription per country — Market Access Essentials at USD 7,500 per year per country for the first device family — where global RA consultancies typically bill those as separate line items and quote USD 15,000–30,000 per country for registration alone.
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 published Mexico/Brazil sticker is $2,000–$3,000 (PR Newswire, 5 February 2026; pricing page). This page does not invent a Pure Global tecnovigilancia dollar figure — unpublished / billed later. Full include/exclude table — bioaccess® vs Pure Global.
Tecnovigilancia is not a PMS add-on. It is how the titleholder keeps the registration legal. In Mexico, Brazil, and Colombia the local holder must run a named system — UVT, professional, SOPs, AE clocks — after the certificate is granted (LGS art. 262 Bis; NOM-240-SSA1-2012 §6.7.12; RDC 67/2009 art. 3; Res. 4816/2008). If that system fails, the registro can be suspended or cancelled and the device cannot legally stay on the market. The bioaccess® LATAM Launch Subscription is USD 7,500 per year per country because we are the holder and we run that system. Pure Global’s published Mexico/Brazil sticker is $2,000–$3,000 for dossier + holder; they describe “post-market support,” do not publish a tecnovigilancia price, and except large-scale vigilance.
Bought separately — at the low-to-mid end of what competitors publish — this is what the same scope costs for one country, first year:
| What it is | Typical separately-billed cost |
|---|---|
| Registration project: dossier preparation, submission, agency management | $15,000 (global consultancies quote $15,000–$30,000 per country for registration alone) |
| Government submission fees | $3,000 (typical range $1,500–$5,000) |
| Certified / sworn translations: IFU, labels, technical file | $8,000 (typical range $4,000–$15,000) |
| In-country registration holder / registered agent | $4,000 (typical range $3,000–$5,000/year) |
| Tecnovigilancia as holder | Quoted separately — competitors do not publish a price |
Typical separately-billed total: $30,000+ per country, per year.
LATAM Launch Subscription: $7,500 per country, per year.
One flat fee. No line items. No surprise invoices. No sticker shock. And the translation memory we build for your dossier is your property.
Per family, not per listing. A five-model device family costs one subscription — $7,500 — at bioaccess®. Vendors that price per device listing charge per model, so the same family can cost five times their sticker before a single government fee or translation is added.
For multi-country LATAM launches with trial-to-market continuity, we believe it's the best value in the market.
Typical time-to-registration once the dossier is submitted: 90 days for low-risk devices and 120 days for Class II/III — varying by country and classification (ANVISA notificação for Class I/II or registro up to ~250–365 days statutory maximum for Class III/IV; COFEPRIS ~30/35/60 working days by class; INVIMA automatic issuance for Class I/IIa or ~90 business days for Class IIb/III), and excluding health-authority queries and audit scheduling outside our control. Every proposal includes a committed submission schedule: if we miss our committed date, you receive a credit against that country's annual fee.
Four things we put in writing, in every proposal:
And one thing we will never do: promise you the regulator's decision. Nobody controls COFEPRIS, ANVISA, or INVIMA — any firm that guarantees an approval is selling fiction. We guarantee everything we control, in writing. That is the deal.
Because the registration dossier is the story of your device, and the company that ran the trial already knows the story. The investigators, the protocol deviations, the safety narrative, the risk profile — our regulatory team works from the study it watched happen, not from files handed over a wall. One team, one translation memory, one accountable holder from first patient to commercial sale.
bioaccess® runs the country-by-country sanitary registration on your behalf — INVIMA (Colombia), COFEPRIS (Mexico), ANVISA (Brazil), ANMAT (Argentina), ISP (Chile), DIGEMID (Peru), MINSA (Panama), ARCSA (Ecuador), DNM (El Salvador), DIGEMAPS (Dominican Republic). In-country legal representation, government submission fees, and certified Spanish/Portuguese translations (sworn where required in Brazil and Argentina) are included in the annual subscription. bioaccess® obtains in-country sanitary registration for devices you have already cleared or approved by the FDA (510(k) / PMA) or CE-marked — we do not obtain FDA clearance or CE marking on your behalf.
Several LATAM markets offer relatively fast device pathways: Argentina (ANMAT) uses a risk-based classification with expedited sworn-declaration filing for lower-risk classes (experience-based, not a statutory cap); El Salvador (DNM via SRS) approves in ~30–60 days; Chile (ISP) runs 30–90 days (experience-based); Colombia (INVIMA) issues Class I/IIa registrations automatically and reviews Class IIb/III in ~90 business days. Mexico's COFEPRIS equivalence route (vía abreviada) carries a ~30-working-day processing target for eligible devices. Timelines vary by class; agency queries pause any statutory clock.
Yes. Every LATAM regulator ties a device registration to an in-country legal entity. In Colombia, Mexico, and Brazil the Holder can add multiple importers; Argentina's Holder is the sole importer of record; Peru requires imports through a licensed droguería. bioaccess® holds registrations through its own dedicated local entities — packaged as named holder products (bioaccess® BRH, MRH, and country holders) — with defined transfer provisions in your agreement if you ever change partners or establish your own entity — your registration is never leverage against you. See LATAM Importer of Record.
Emergo by UL is a global regulatory consultancy that acts as in-country representative in five LATAM markets (Brazil, Mexico, Peru, Colombia, Costa Rica). bioaccess® covers 19 LATAM markets through its own entities, bundles translations and tecnovigilancia into one flat annual fee, and — uniquely — can carry your device from first-in-human trial through registration with the same team.
Freyr is a global regulatory consultancy selling strategy and submissions across 120+ markets. bioaccess® is LATAM-native: our teams are in the region, our translations are produced in-house (not outsourced), our holder entities are our own, and our regulatory practice sits next to a first-in-human CRO — so your clinical data flows straight into your dossier.
Pure Global publishes a $2,000–$3,000 annual sticker for dossier + holder in Brazil, Mexico, and Colombia. The bioaccess® LATAM Launch Subscription (USD 7,500/year per country) is a different SKU: registration + holder + government fees + sworn translations + tecnovigilancia as holder, across 19 markets, with in-house translation production and a trial-to-market bridge no flat-fee vendor can offer.
Typical time-to-registration once the dossier is submitted: 90 days for low-risk devices and 120 days for Class II/III, varying by country and classification. ANVISA (Brazil) notificação for Class I/II or registro subject to statutory maximums up to ~250–365 days for Class III/IV; COFEPRIS (Mexico) ~30/35/60 working days by class, with a ~30-working-day equivalence-route (vía abreviada) target for eligible devices; INVIMA (Colombia) automatic issuance for Class I/IIa or ~90 business days for Class IIb/III. Excludes health-authority queries and audit scheduling outside our control. Submission workmanship is backed by the bioaccess® Submission Guarantee (full terms in proposal).
Market Access Essentials / LATAM Launch Subscription is USD 7,500 per year per country for the first device family (unlimited models, references, and variants within that family). Mexico Class III / energy is USD 10,000/year; Brazil Class III/IV is USD 12,000/year + INMETRO pass-through; Class IIb Professional is ~USD 15,000/year. The card includes government submission fees, certified/sworn translations, in-country titular/RH/IOR, and tecnovigilancia as holder. Additional families: USD 3,500 (low–mid, any country); USD 4,500 (Class III / high-risk Mexico); USD 5,500 (Class III / high-risk Brazil). Multi-country and clinical-trial-client discounts apply — the proposal states which discount applies; they do not auto-stack unless the signed proposal says so. Brazil BGMP/INMETRO/ANATEL and RF telecom homologation are separate third-party certifications billed at vendor cost + 20% G&A. Desktop publishing / visual replication (tables, scanned PDF layout, DTP) and large-scale Field Safety Corrective Action (FSCA) / recall campaigns sit outside the flat fee. Full rate card.
Market Access Starter (USD 3,900/year per country) is the entry tier for simple cases: a single device model, low-risk classes only (Class I/IIa or country equivalent), one country. It's fully all-inclusive — registration project, in-country holder + importer of record, government fees, certified translations, tecnovigilancia, post-approval modifications, and agency liaison. Adding a second model moves you to the $7,500 Market Access Essentials family subscription. The same multi-country discounts (10% at 3+, 15% at 5+) and the 20% Trial-to-Market Bridge apply.
Different SKUs. Their published Mexico/Brazil sticker is $2,000–$3,000 for dossier + holder. They describe “post-market support,” do not publish a tecnovigilancia price, and 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 — the legal system that keeps the registro live. Tecnovigilancia is not a PMS add-on. If that system fails, the certificate can die and the device cannot legally stay on the market.
The subscription is annual. Every agreement carries defined transfer provisions: if you ever change partners or establish your own entity, the registration transfers on a contractual timeline — your registration is never leverage against you. Full renewal and termination terms are set out in your proposal and MSA.
LATAM Importer of Record — country-by-country rules · First-in-Human CRO · First-in-Human Clinical Trials pillar
Last reviewed: September 2026.
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Generating the clinical data is only half the journey. We also help manufacturers register and hold their device across Latin American markets, so the same partner that ran your first-in-human study can carry you into commercialization.