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.
Flat annual subscription per country. The base fee covers your first device family — all models, references, and variants within that family, as defined in your agreement. Additional families are charged per family per year.
What many competitors invoice separately after the contract is signed — translations, government fees, registered agents, regulatory liaison — is already included in the bioaccess® 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.
Worked example — Class II device across 4 countries (Brazil ANVISA, Mexico COFEPRIS, Colombia INVIMA, Chile ISP): the bioaccess® all-inclusive annual fee is USD 30,000 base minus a 10% multi-country discount = USD 27,000. A typical competitor first-year total is approximately USD 60,500 (USD 27,000 base registration + USD 8,000 government submission fees + USD 22,000 translation + USD 3,500 in-country registered agents) — a saving of roughly USD 33,000 in year one. This is the conservative case: it assumes an identical base registration fee, even though typical competitors quote USD 15,000–30,000 per country for registration alone. Based on quotes and published pricing for equivalent scope obtained as of July 2026; individual quotes vary by consultancy.
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).
Flat annual subscription per country. USD 7,500/year covers the first device family in most countries; Mexico Class III USD 10,000/year; Brazil ANVISA Class III/IV USD 12,000/year. Each additional device family: +USD 3,500/year low-to-mid risk, +USD 4,500/year Mexico or +USD 5,500/year Brazil for Class III. Multi-country discounts: 10% off at 3+ countries, 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Brazil BGMP/INMETRO/ANATEL and RF telecom homologation are separate third-party certifications billed at vendor cost + 20% G&A.
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.