Your device is already cleared. bioaccess® registers it and holds it across Latin American markets — sanitary registration, in-country registration holder and importer of record, certified translations, and government fees, all inside one annual subscription. This is the LATAM Launch Subscription. Six core markets detailed below; coverage across 19 LATAM markets — full list on request.
Coverage across 19 LATAM markets; devices registered in 5+ to date.
bioaccess® track record as of July 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 framework is evolving; registration and pathway are confirmed at proposal stage. Typical timeline 30–90 days. bioaccess® manages the ISP registration process.
Peru's DIGEMID regulates medical device imports and registration. bioaccess® manages DIGEMID registration and market entry.
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 are quoted on request.
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.
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.
We control our work; regulators control theirs. We guarantee what's ours — your complete dossier submitted, in certified Spanish or Portuguese, with all government fees paid, on the committed schedule, or we credit a portion of that country's annual fee. Full terms in your proposal.
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 for your benefit, 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.
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 are quoted on request. Multi-country and clinical-trial-client discounts apply. Brazil BGMP/INMETRO/ANATEL and RF telecom homologation are separate third-party certifications billed at vendor cost + 20% G&A.
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.
LATAM Importer of Record — country-by-country rules · First-in-Human CRO · First-in-Human Clinical Trials pillar
Last reviewed: July 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.