cms.bioaccessla.com

Category: Market Access Services in Latin America

Explores the regulatory requirements and best practices for obtaining marketing authorization, market clearance, and regulatory registrations in the top Latin American countries—Mexico’s Cofepris, Colombia’s Invima, Brazil’s Anvisa, and Argentina’s Anmat—market entry, and market access in Latin America, focusing on innovative medical devices.

  • ANMAT clinical-trial submission checklist for medical device studies in Argentina

    Sponsors keep asking what ANMAT requires for clinical trials in Argentina as if one ninety-day bar covered ethics, investigation authorization, investigational import, and later commercial registro. It does not. ANMAT is one agency name on two files. Confusing them is how an Argentina Gantt goes soft.

    I am Julio Martinez-Clark, CEO of bioaccess®. This checklist is for medical-device clinical-investigation filings in Argentina. It is grounded in the live ANMAT trial authorization vs registro post, the investigational import guide, and the market-access hub. It is not a quote and not legal advice. Confirm every instrument against ANMAT’s current published texts before you file.

    Separate the two ANMAT files first

    Write two columns on one page before translators start:

    1. Investigation file. ANMAT clinical-investigation authorization for a first-in-human (FIH) or early feasibility study (EFS), plus independent ethics review under ISO 14155 and the Declaration of Helsinki, and provincial oversight where it applies (for example Buenos Aires). Success criterion: authorized research use of the named investigational article.
    2. Registro file (commercial, later or parallel only if truly in scope). Sanitary registration for Classes I–IV under Disposición ANMAT N° 64/2025, including the simplified declaración jurada (DDJJ) route for CE-marked Class I/II through HELENA, with a local authorized representative / Technical Director ANMAT will treat as responsible for that certificate. Success criterion: a selling license — not a trial letter.

    If the board slide says “ANMAT approved,” ask which ANMAT. Trial authorization is not a selling license.

    Governing desks on the investigation track

    • ANMAT — Dirección de Investigación Clínica. Disposición ANMAT 7516/2025 Article 5 assigns clinical-investigation evaluation to that directorate. The Colombia execution pillar already notes that disposition states no binding day-count for that evaluation desk in the same way some markets publish one; Argentina’s published planning framework for device investigations on our Argentina trial page remains the 90-business-day statutory review target that pauses for RFIs. FIH/EFS device studies often exceed that target. Treat 90 business days as a planning framework, not a guaranteed total start-up time.
    • Independent ethics committee. Protocol, Spanish informed consent, and investigator packet. Ethics is a gate on the trial track, not a commercial license.
    • Provincial oversight where required. File federal, ethics, and provincial packages in parallel when the study design allows it. Sequential filing adds calendar the statutory target never promised to absorb.
    • Investigational import. Authorization linked to the ANMAT trial approval, through a licensed importer of record, with a device-level manifest. A commercial registro number does not clear investigational kits. Argentina’s import documentation is exacting — reconcile every document before filing (see the regional import guide).

    Submission checklist (investigation dossier)

    Assemble the universal FIH core once, then layer Argentina’s desks. Do not invent form codes that are not on the live bioaccessla.com pages — use this operator checklist against ANMAT’s current published requirements at filing time.

    Section What to freeze Operator check
    Protocol Version, endpoints, stopping rules, schedule of events Same version across ANMAT, ethics, and provincial packs
    Investigator’s brochure / preclinical Risk profile for first human use Matches the article on the investigational device list
    Informed consent (Spanish) Ethics-ready language for Argentina Not the commercial IFU you will later lock on a registro
    Case report form Locked before site training Version matches protocol
    Insurance Trial-related injury coverage in the form Argentina requires Territory and named parties match the sites
    ISO 14155 monitoring plan GCP bridge for foreign data If U.S. filing is intended, design for 21 CFR § 812.28 inspectability from day one
    Investigational labeling For clinical investigation only Lot/serial traceability matches site accountability
    Device / accessory list Every unit that will sit in the accountability log Quantities match what import will request
    Importer of record Legal name before ethics stamps the protocol Document ties shipment to investigation authorization — not HELENA DDJJ, not a cousin SKU’s registro
    Ethics + provincial letters Independent committee; provincial filings where required Keep correspondence in one trial master file

    What this checklist is not

    • It is not the commercial Classes I–IV / HELENA map under Disposición 64/2025. That is the market-access track and the live ANMAT registration checklist.
    • It is not an importer-of-record substitute for a sanitary registration holder. Argentina is a strict single-IoR example on the commercial track (authorized representative under Disp. 64/2025). That holder conversation belongs on market access. It does not clear investigational freight for a FIH.
    • It does not claim ANMAT is a PAHO/WHO Level 4 authority, and it does not invent an ICH-member claim — those claims are not published on this site.

    Import: investigational units are not the registro SKU

    Name the trial importer before ethics stamps the protocol. Map every investigational model, accessory, and spare to the investigation-authorized list. Outer labels must read as investigational. After last patient, close investigational inventory under the trial rules. Leaving units “for the hospital” without a new sanitary path is a new regulatory event, not a courtesy.

    Hand-carry is not the plan. Formal, traceable importation tied to the trial authorization is required across Latin America; Argentina is not an exception.

    If the Argentina FIH must support a U.S. file

    Design the investigation so the evidence room can satisfy 21 CFR § 812.28 (acceptance of data from clinical investigations conducted outside the United States): GCP, independent ethics review, and a device comparable to the version you will put in front of FDA. ISO 14155 is the device GCP bridge FDA has publicly recognized for foreign investigations. A clean ANMAT investigation letter does not replace an inspectable trial master file. Keep device accountability, deviation logs, monitoring reports, ethics correspondence, and provincial letters in one place from day one. Eligibility of foreign data under § 812.28 is not a clearance prediction.

    Common rejection / delay patterns

    • One 90-day bar for both desks. Treating the statutory trial review target as if it also covered Classes I–IV commercial registration. Higher-risk commercial work often runs several months on experience, not on the trial clock.
    • Registro number on investigational freight. Using a commercial ANMAT certificate for a predicate or related model to move FIH units.
    • One Spanish translation for both desks. Ethics/investigation language is not the commercial IFU ANMAT will later lock on a registro.
    • Importer named after first patient. Import documentation then becomes the critical path the ethics letter cannot fix.
    • RFI pause ignored on the Gantt. The 90-business-day target pauses for requests for information. Budget response time.

    One-page gate before first patient in Argentina

    • Authority map: ANMAT investigation + independent ethics (+ provincial where required) versus commercial registro under Disp. 64/2025 / HELENA only if launch is truly in scope this year.
    • Same protocol version and same Spanish informed-consent text across federal, ethics, and provincial packages.
    • Investigational importer named, with the document that ties the shipment to the investigation authorization.
    • Device list complete, including accessories.
    • ISO 14155 file owner who can produce monitoring, accountability, and ethics letters within 48 hours if FDA or a notified body asks.
    • Commercial holder (optional, separate): Argentine authorized representative / Technical Director kept off the FIH critical path until first patient is locked.

    Related reading on bioaccessla.com

    Planning an Argentina FIH or EFS investigation file — separate from registro? bioaccess® runs FIH/EFS execution across Latin America, including Argentina from Miami, and holds LATAM registration/IOR work as a separate market-access track. Contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    What are ANMAT requirements for clinical trials in Argentina?

    For devices, expect an ANMAT clinical-investigation file evaluated via the Dirección de Investigación Clínica (Disposición 7516/2025 Art. 5), independent ethics review, provincial filings where required, investigational labeling and import tied to the trial authorization, and an ISO 14155-ready trial master file. Commercial registro under Disposición 64/2025 / HELENA is a second petition.

    Does the 90-business-day clock cover commercial registration?

    No. The 90-business-day statutory target on our Argentina investigation pages is a planning framework for the trial review that pauses for RFIs. Classes I–IV registro is a separate file and clock.

    Can we use a commercial ANMAT number to import FIH units?

    No. Investigational units need import authorization linked to the trial approval. A registro number for a related commercial SKU does not clear the investigational article.

    Is the registration holder the same as the trial importer?

    Not automatically. Argentina’s commercial track is a strict single-IoR / authorized-representative posture under Disp. 64/2025. Name the trial importer for the investigation; keep the sanitary registration holder on the market-access track.

    Will FDA accept Argentina FIH data?

    Foreign clinical data may be eligible for FDA consideration under 21 CFR § 812.28 when GCP, ethics, and device comparability are documented. Eligibility is not a clearance or approval prediction.

  • The Independent Sanitary Registration Holder Strategy: Avoiding Distributor Lock-In Across LATAM

    The fastest way to lose control of a Latin America launch is to let the first distributor become the sanitary registration holder. The commercial conversation sounds efficient: “They already import, they already know COFEPRIS / INVIMA / ANVISA, put the certificate in their name.” Six months later the independent registration holder Latin America medical device option is gone, and every channel change becomes a regulatory project. This brief is how manufacturers avoid that lock-in — and how independent third-party titularidad keeps multi-distributor agility intact.

    I am Julio Martinez-Clark, CEO of bioaccess®. We hold registrations through our own local entities for the manufacturer’s benefit. The public product card is the LATAM Launch Subscription at USD 7,500 per year per country for the first device family (published 23 August 2026). This page is strategy, not a quote. Confirm country-specific holder rules in the proposal.

    1. The distributor-as-holder trap

    Every major Latin American health authority ties a device registration to an in-country legal entity. That entity is the titular, detentor, representante autorizado, or registration holder. On that name sit tecnovigilancia, answers to the authority, variations, renewals, and — in several markets — importation rights. The distributor is a different job: sells, invoices, trains, services. When both jobs sit in one company, you do not have a channel partner. You have a partner who also owns the regulatory asset.

    How the trap usually forms:

    • Speed bias. The commercial team wants a LOI this quarter. The distributor offers to “handle registro.” Filing in their name is faster than standing up an independent holder — until you need to exit.
    • Invoice confusion. Government fees and agent retainers get bundled into the distribution margin. Finance never sees a separate holder line, so nobody owns the certificate as an asset.
    • Assumed portability. Teams assume “we can transfer later.” In many markets, transfer is a cesión de derechos, a new registro, or both — with months of downtime and a second full dossier.
    • Single-door import. When the holder is also the exclusive importer, terminating the commercial relationship can strand inventory and freeze new shipments even if patients and hospitals still want the product.

    The operating rule is simple: holder and distributor are separate roles unless you deliberately choose otherwise. Write that into the distribution LOI before anyone files. If the LOI is silent, the first filing will decide for you.

    2. The cost of transferring registrations

    Transfer cost is not only the government fee. It is calendar, dossier rebuild, and commercial interruption.

    Mexico (COFEPRIS). The named titular on the Registro Sanitario is the sanitary face of the product. If the distributor is the name on the public Visor de Registros Sanitarios de Dispositivos Médicos, channel termination does not move the certificate. You negotiate a cesión or re-register. Either path needs a complete technical file, updated labels, and a vigilance handoff. While that runs, the outgoing holder still owns the legal duties — including tecnovigilancia under the applicable Mexican framework (including NOM-240-SSA1-2012 expectations for the titular).

    Brazil (ANVISA). RDC No. 751 of 15 September 2022 names a single detentor de registro. The foreign manufacturer cannot be that detentor. Changing detentor is a regulated event, not a contract amendment. RDC 270/2019 already lets one detentor authorize several importers without re-registering the device — which is exactly why an independent Brazil Registration Holder is the correct design and a distributor-detentor is expensive to unwind.

    Colombia (INVIMA). Decreto 4725 of 2005 is the sanitary-registration statute. INVIMA contemplates one titular with the ability to work through importers. Handing titularidad to the first commercializer turns every later distributor change into a regulatory file. Colombia remains a core market-access geography for bioaccess®; keep the commercial registro on an independent holder even when investigation work sits elsewhere.

    Central America and single-representative markets. Panama (Ley 90 of 2017 and Decreto Ejecutivo No. 490 of 4 October 2019), El Salvador (SRS / DNM commercial track), Dominican Republic (DIGEMAPS), and similar single-authorized-representative models make holder changes especially painful: the representative is often titular and importer in one. Changing AAR frequently means registering again. Budget that as a new market entry, not a paperwork afternoon.

    Hidden line items on every transfer. Certified Spanish or Portuguese retranslation if the outgoing distributor owned the glossary; new label artwork; updated importation permits; training the new vigilance contact; explaining to hospital procurement why the sanitary number’s legal face changed. Sponsors who “saved” a year-one holder fee typically spend it back in year-two exit costs — plus lost quarters of revenue.

    3. Country titularidad frameworks (INVIMA, COFEPRIS, ANVISA, Central America)

    Classification and holder rules diverge. Do not paste a single “Class II + local agent” row across nineteen countries.

    COFEPRIS (Mexico). Reglamento de Insumos para la Salud Article 83 uses a three-class logic where duration-in-body and novelty drive Class II versus Class III. A Mexico Registration Holder that is not the exclusive distributor can name several distributors and importers on one certificate. That is the structural reason independent titularidad pays for itself in Mexico: one sanitary face, many commercial doors. Check the named titular on the public visor once the registro is vigente.

    ANVISA (Brazil). Four classes under RDC 751/2022; Classes I/II often go to notificação and Classes III/IV to registro, with long statutory maximums for higher-risk files. Implantable and long-term surgically invasive devices default toward higher classes unless a specific rule says otherwise. The detentor runs the post-market system (including obligations under frameworks such as RDC 67/2009 for tecnovigilância). Independent holder plus authorized importers under RDC 270/2019 is the multi-channel design.

    INVIMA (Colombia). Four classes with a IIa/IIb split under Decreto 4725 of 2005. Class I and IIa can receive registro sanitario automático; Class IIb and III take prior review on the order of roughly ninety business days. Titularidad should sit with an entity that answers to the manufacturer’s transfer doctrine — not with whichever distributor won the first tender.

    Central America. Treat Panama, El Salvador, Costa Rica, Guatemala, Honduras, Nicaragua, and the Dominican Republic as a family of single-representative or tightly coupled holder–importer models, each with its own statute. The shared operating lesson: do not assume a Mexican multi-importer pattern exists. Confirm whether one authorized representative is also the only legal importer before you sign an exclusive distribution agreement that conflicts with the sanitary fact.

    Argentina, Peru, Chile (for completeness). ANMAT’s authorized representative logic (Disposición 64/2025 replacing older AAR instruments), Peru’s DIGEMID droguería/titular model under Ley N° 29459 and Decreto Supremo N° 016-2011-SA (with Decreto Supremo N° 001-2024-SA supporting independent Peru Registration Holder designs), and Chile’s ISP regime all reward the same doctrine: name the holder on purpose before the channel LOI.

    Ethics and trial authorization are a different desk from commercial titularidad. If you still need patients, keep the investigation file off the commercial holder track — the same separation we argue on the centralized vs decentralized ethics review brief. Mixing clocks creates rework that looks like “LATAM delay” and is actually self-inflicted file contamination.

    4. Independent holder enables multi-distributor agility

    Independent third-party titularidad is not a legal curiosity. It is the operating system that lets commercial strategy change without burning the sanitary asset.

    What “independent” means in practice:

    1. The holder does not sell the device. No conflict between margin and vigilance. No incentive to slow a competitor distributor’s import authorization.
    2. Transfer provisions are written up front. The manufacturer can move or reclaim the registro under defined conditions without inventing a negotiation during a channel fight.
    3. Importer lists follow the sanitary rules of each country. Mexico, Colombia, and Brazil (under RDC 270/2019) can support multiple importers on one registration design; single-representative markets need a different commercial map. Write contracts to the sanitary fact.
    4. Tecnovigilancia stays continuous. Field actions, periodic reports, and authority queries do not restart every time sales leadership changes distributors.
    5. Translation memory stays with the manufacturer. IFU, labels, and technical-file Spanish/Portuguese should not live only on a distributor’s laptop.

    Multi-distributor agility — concrete outcomes:

    • Appoint a hospital-focused distributor in one region and a retail or tender-focused partner in another without splitting the registro.
    • Replace an underperforming partner without a year of re-registration downtime.
    • Add an importer for a new procurement channel while the same titular answers COFEPRIS, INVIMA, or ANVISA.
    • Keep Global Trial Accelerators™ clinical programs and commercial launch on separate rails: investigation units use the trial importer; commercial SKUs use the holder/IOR design on the market-access hub.

    bioaccess®’s published structure is that independent holder across a 19-market footprint, executed through our own local entities. As of the July 2026 market-access card: 25+ device registrations completed; 25+ active registrations held through bioaccess® entities; 15+ years on COFEPRIS, INVIMA, ANVISA, and ANMAT (self-reported). The USD 7,500/year LATAM Launch Subscription for the first device family bundles government submission fees, certified translation with manufacturer-owned translation memory, in-country titular/holder/IOR, post-approval modifications, agency liaison, and tecnovigilancia as holder. Higher-risk Mexico and Brazil SKUs and multi-country discounts are on the live card — do not invent rates here.

    Site and investigator network questions for trials belong on the network page; commercial holder strategy belongs on market access. Do not hire a new local agent per capital if the plan is several certificates under one transfer doctrine.

    Build the holder map before the LOI

    1. List every launch country and write who will be titular / detentor / AAR — manufacturer branch, independent professional holder, or distributor — on purpose.
    2. For each country, write who may import and whether multiple importers are legally available.
    3. Forbid distributor-as-holder in the LOI unless the board explicitly accepts lock-in.
    4. Put maintenance on a flat annual subscription so variations, renewals, and vigilance are not a new consulting event every quarter.
    5. Keep ethics/trial authorization off the commercial certificate path.

    Learn about independent registration holding and the bioaccess® LATAM Launch Subscription at bioaccessla.com/market-access. Related: site network and centralized vs decentralized ethics review in LATAM.

  • Chile’s Easy Market Ends in 2028: Exempt Decree No. 25 and ISP Registration

    Source: This article adapts and expands themes from Julio G. Martinez-Clark’s guest column on Med Device Online (published September 11, 2026): “Chile’s Easy Market Ends In 2028.” Read the full column there; what follows is an original bioaccess® operator brief for manufacturers building a Latin America (LATAM) market-access plan — not a reprint.

    For years, Chile was the LATAM medtech market where a strong distributor and an importer of record (IOR) could often move faster than a full sanitary-registration campaign. Only a short mandatory list — contraceptives, gloves, needles, and syringes — required Instituto de Salud Pública (ISP) registration for most commercial paths. In 2021 I asked on Med Device Online how long that “easiest market” window would last. Exempt Decree No. 25 answers it: the easy years run through 2026; the compressed years are 2027–2028.

    What changed: Exempt Decree No. 25

    On March 19, 2026, Chile published Exempt Decree No. 25 in the Diario Oficial (Núm. 44.404, CVE 2781436). The decree pulls 39 numbered medical device and in vitro diagnostic (IVD) types into the sanitary-control regime under Article 111 of the Health Code and Decree Supreme No. 825. ISP describes the set as higher-risk, widely used products tied to ministerial programs, with conformity verification based on quality, safety, and performance documentation.

    The legal machinery was already there — Decree Supreme No. 825 long required conformity-verification certificates for covered devices. Earlier exempt decrees had used that structure for narrow categories (for example sterile hypodermic needles and syringes). The difference now is scale: 39 types, including software as a medical device and multiple IVDs, phased into mandatory ISP sanitary registration.

    Two waves — and why the calendar is not the real clock

    First wave (24 months / 13 types in Artículo primero transitorio): deadline March 19, 2028. Includes cardiovascular implants and catheters, heart valves, cochlear implants, orthopedic and soft-tissue implants, copper intrauterine devices (IUDs), insulin infusion pumps and accessories, blood bags, and related numbered types in the decree.

    Second wave (36 months): deadline March 19, 2029. Includes imaging, radiotherapy, dialysis, ventilation, extracorporeal circulation, electrosurgical, ophthalmic, continuous glucose monitoring (CGM), continuous positive airway pressure / bilevel positive airway pressure (CPAP/BPAP), sterilization, oncology software, and several IVD categories.

    Seeing 2028 and assuming “plenty of time” is the first operational mistake. Decree No. 25 gives ISP up to 12 months from publication to issue the technical instruction for conformity verification. Voluntary filing is allowed only after that instruction exists. If the how-to lands near the 12-month mark, manufacturers in the first wave may have roughly one usable year — not two — to interpret requirements, assign ownership, assemble and translate files, close standards gaps, coordinate Chilean partners, submit, answer questions, and obtain registration. That is a compressed portfolio campaign, not a leisurely runway.

    Registration readiness now beats distributor-first strategy

    Chile’s older entry model made distributor selection the first strategic move. After the applicable transition dates, covered products may only be manufactured in Chile, imported, marketed, or distributed with the required conformity verification — which the decree frames as ISP sanitary registration. That shifts commercial leverage: if the distributor imports but nobody owns the Chile file, modification path, and continuity if the channel changes, you have built regulatory risk into the sales model.

    Treat this as a LATAM market-access problem, not a one-country paperwork chore. Many manufacturers still use Chile as an early regional entry point because of institutional stability and provider quality. When Chile stops being “import and sell,” the regional launch sequence changes. Map registration and portfolio triage before you lock distribution strategy. (For how bioaccess® packages market-access work, see the market-access rate card — without inventing case-specific rates here.)

    Do not confuse pathways. A clinical-trial authorization or investigational import route is a different file from commercial sanitary registration. It is not 2028 commercial cover. For Chile clinical-operations context, see our Chile clinical trials country page; keep investigational and commercial tracks separate in governance.

    Standards, Spanish dossiers, and postmarket (tecnovigilancia)

    Decree No. 25 points manufacturers toward an explicit standards-based review — including general references such as NCh ISO 16142 (parts 1 and 2), NCh ISO 13485, and NCh ISO 14971, plus product-specific standards for the 39 categories. Chile-ready work is a technical-file readiness exercise, not a local stamp.

    ISP guidance on essential principles of safety and performance already expects devices and IVDs to meet intended performance with risks acceptable relative to benefit, and to ship identification, safety, and use information in castellano (Spanish). Existing FDA, EU MDR, MDSAP, or ISO 13485 packs help — they are not automatically a Chile dossier. Family/group/system filings may not match Chile’s grouping expectations; labels and instructions for use (IFU) may need Spanish updates; legacy lines may have documentation gaps.

    Waiting for ISP’s technical instruction before doing any work wastes the only runway that matters. As of late August 2026 that instruction had not been issued. Final forms can wait; portfolio mapping, standards-gap assessment, Spanish labeling review, and local-role design cannot.

    Postmarket is part of the transition. ISP’s announcement on Decree No. 25 frames the reform as support for postmarket surveillance. Chile already operates tecnovigilancia (technovigilance) enrollment and adverse-event reporting expectations — including precise device identification (lot, model, series, manufacturer, intended use), not generic labels like “catheter” or “valve.” Traceability under related Chilean technical norms belongs in the same operating model as registration. Approval without a Chile-specific complaint, reporting, field-action, and file-sync plan is incomplete market access.

    Five triage moves manufacturers should make now

    1. Map the decree to the live Chile catalog — every model, accessory, software module, kit, and family currently sold, against scope and transition group.
    2. Rank by two-year commercial necessity — some legacy SKUs will not justify registration; platform anchors and consumables drivers often will.
    3. Assess technical-file readiness before the instruction drops — risk management, QMS certificates, Spanish labeling, accessory documentation.
    4. Define local responsibility — who files, maintains, modifies, answers ISP, and owns postmarket vigilance; “the distributor” is an answer only if it protects long-term flexibility.
    5. Budget a multiyear wave — governance, timelines, document owners, escalation — not a one-off filing event.

    What 2021 got right — and what the instruction gap changes

    Directionally, the 2021 Med Device Online column was right: Chile was not going to stay unusually open forever. The vehicle that landed is Decree No. 25 via the Ministry of Health and ISP (with ANDIM in the implementation picture), not the legislative script many watched at the time. Scope is larger than the old four-category mandatory list — 39 numbered types. The underweighted piece in 2021 was the instruction gap: a two-year transition looks generous until the agency has up to a year to write the how-to and early filing is gated on that how-to.

    Chile remains a serious, commercially attractive market with its own regulatory culture. What ended is the assumption that listed device types can enter without a sanitary-registration strategy. Map the catalog now.

    References

    1. Julio G. Martinez-Clark, “Chile’s Easy Market Ends In 2028,” Med Device Online, September 11, 2026 — https://www.meddeviceonline.com/doc/chile-s-easy-market-ends-in-0001
    2. Julio G. Martinez-Clark, “Medtech In Chile: Currently Latin America’s Easiest Market, But For How Long?” Med Device Online — https://www.meddeviceonline.com/doc/medtech-in-chile-currently-latin-america-s-easiest-market-but-for-how-long-0001
    3. Ministerio de Salud de Chile, Decreto Exento N° 25, Diario Oficial March 19, 2026, Núm. 44.404, CVE 2781436 — https://www.bcn.cl/leychile/navegar?idNorma=1222514
    4. Ministerio de Salud de Chile, Decreto Supremo N° 825 — https://www.bcn.cl/leychile/navegar?idNorma=141005
    5. Instituto de Salud Pública de Chile, announcement on the new norm regulating 39 medical devices including IVDs — ISP notice

    Disclaimer: This post is general information for educational and commercial-planning purposes. It is not legal advice and is not a substitute for advice from qualified Chilean counsel or confirmation with ISP on current filing instructions, product classification, or transition applicability to a specific portfolio.

    bioaccess® helps manufacturers sequence LATAM market access — registration ownership, IOR design, and distributor strategy — so Chile’s 2028/2029 waves do not become a last-minute scramble. Contact bioaccess® · Book a meeting

  • Compassionate use vs post-trial access in Latin America: do not file the wrong petition

    U.S. teams often arrive in Latin America with one phrase — “compassionate use” or “expanded access” — and expect a single regional petition that keeps patients on product after a trial. That phrase does not map cleanly onto the instruments that actually govern continued supply in the region. Post-trial access (PTA) after an authorized study is usually a different legal object from named-patient / exceptional-import routes. Filing the wrong one produces per-patient dossiers, wrong desks, and gaps at last-patient-last-visit.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page separates those routes using instruments already published on bioaccessla.com — starting with the LATAM post-trial access operator map and the country pillars for Argentina, Brazil, Panama, Chile and Costa Rica. It is not a quote and not legal advice. For operator diligence questions, use how to evaluate a LATAM PTA operator.

    Two problems that share vocabulary

    Write the board question before you ask regulatory for a “compassionate use letter”:

    • Post-trial access (cohort continuity). Identified participants who completed (or still sit in) an authorized clinical trial need continued investigational or successor product because benefit was shown or the statute / ethics framework requires free continuity. The filer is usually the sponsor. The cohort is defined by the trial.
    • Named-patient / exceptional / RAEM-style access. An individual patient outside a trial dossier — or treated as if outside it — needs a medicine or device that is not locally registered, often on a treating physician’s request, with quantity and validity windows that look nothing like a trial extension. The filer is often the patient, family, or a physician — not the sponsor cohort manager.

    U.S. FDA expanded access under 21 CFR 312 Subpart I is a permissive framework for use outside clinical trials. Puerto Rico sits in that U.S. customs picture on our operator map. Most LATAM countries either (a) impose a binding PTA duty after a trial, (b) offer a separate exceptional-import path, (c) soft-route continuation into “compassionate use” language, or (d) impose nothing. Mixing (a) with (b) is the filing error this page exists to prevent.

    Where binding PTA actually sits

    Across the twenty jurisdictions on the operator map:

    • Binding statutory mandate (10): Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua, Panama.
    • Binding instrument, weak or unassigned duty (3): Uruguay, Bolivia, Venezuela — including Venezuela’s BPC “procurar” language and Bolivia’s routing of continuation into per-patient DINAMED compassionate-use authorization.
    • No mandate (7): Mexico, Colombia, Paraguay, El Salvador, Dominican Republic, Cuba, Puerto Rico.

    Colombia’s Resoluciones 2378/2008 and 8430/1993 contain no post-trial supply obligation; Res. 8430 allocates only harm-related costs. Mexico’s NOM-012-SSA3-2012 §11.2.2 is an investigator duty about continued treatment and care, not a sponsor duty to keep shipping investigational product. Do not invent a Colombian PTA petition because a U.S. template says “expanded access.”

    Argentina: the cleanest PTA vs RAEM split

    Argentina is the teaching case because both instruments exist in public text and sponsors still swap them.

    Cohort PTA — Disposición ANMAT 12792/2016. This is the procedure for importing post-study medication, treatment and materials for participants in an ANMAT-authorized clinical pharmacology study. Article 3 requires the sponsor to file eight documents before the study ends. Article 4 gives DERM a twelve-month authorization per investigator and center. Article 3(g) requires a sworn declaration that supply is free to the participant, the treating institution, and the health coverage. Article 2 excludes authorized extension studies — those stay on the trial track. Detail: Argentina Disposición 12792 pillar.

    Named-patient exceptional import — Disposición 4616/2019 (RAEM). The Régimen de Accesibilidad de Excepción a Medicamentos makes no reference to clinical trials. Article 2(a) aims at medicines not registered with ANMAT but registered in an Anexo I country under Decreto 150/92, “destinados a tratar un paciente en particular.” Article 4(a) makes the patient (or family / legal representative) the responsible filer on a treating physician’s prescription and prohibits any gestor or intermediary. Article 12 limits Customs validity to 90 days; quantity caps sit at 90 or 180 days depending on course. Using RAEM for a trial cohort produces one expediente per patient, per renewal, on the wrong legal basis.

    If your Argentine continuation plan is “file RAEM for everyone who responded,” you do not have a PTA plan. You have a stack of individual exceptional imports that a sponsor is not even allowed to manage as gestor.

    Brazil: PTA is statute; compassionate / expanded / post-estudo share a service channel

    Brazil is the strongest PTA mandate in the region and still the easiest place to confuse vocabulary with ANVISA’s assistance-program menu.

    • PTA duty: Lei 14.874/2024 Chapter VI (Arts. 30–37) and Decreto 12.651/2025 Art. 31. The sponsor must file a post-study access plan with the CEP before the trial starts, guarantee free supply when the investigator judges the product the best therapeutic alternative, and may interrupt only on listed Article 33 grounds — including five years counted from commercial availability in Brazil. Ministry of Health / INAEP language: continued treatment “não é uma expectativa, mas um dever legal.” Devices and advanced therapies are in scope through Art. 37. Detail: Brazil Lei 14.874 pillar.
    • Import / assistance mechanics: For medicines, RDC 38/2013 still frames compassionate use, expanded access, and post-study supply as assistance programs. Post-study supply gets “um ofício autorizando o fornecimento,” not a comunicado especial (Art. 3 §2). ANVISA’s own public notice on Consulta Pública 1.210/2023 disclosed that between 2019 and 2023 it received 256 post-study supply requests alongside 558 compassionate use and 41 expanded access requests — three different request types on one service family, not one interchangeable petition.

    Operational takeaway: the CEP-approved PTA program and the ANVISA anuência are not optional synonyms for “compassionate use.” A device sponsor also has a statutory duty under Art. 37 while RDC 38/2013 still speaks in medicamento terms — resolve the post-close import path in the protocol, not at close-out.

    Panama, Chile, Costa Rica: PTA without a U.S.-style expanded-access label

    • Panama — Decreto Ejecutivo 21/2026 Art. 68 (Gaceta Oficial 30510-C, 23 April 2026): investigators and sponsors must ensure participant access when clinical or public-health benefit was shown, until commercialization in the country, via extension of the trial import permit for exclusive participant use. This is not Ley 419 de 2024 (the commercial medicines statute) and not the repealed Decreto Ejecutivo 1843/2014 path. Detail: Panama Decreto 21/2026 pillar.
    • Chile — Código Sanitario Art. 111 C (Ley 20.850): continuity “sin costo para el paciente… por todo el tiempo que persista su utilidad terapéutica,” with the duty following the sanitary-registration holder. That is an open-ended free-supply duty, not a 21 CFR Subpart I-style expanded-access grant. Detail: Chile Ley 20.850 pillar.
    • Costa Rica — Ley 9234 Arts. 28 and 53(k): the clearest express device PTA duty in the region — free post-study provision of “el medicamento, dispositivo o procedimiento,” “mientras lo requieran,” with exhaustive exit conditions. The statute mandates supply; it does not hand you a post-trial import route in Art. 55 (which addresses importation before an approved study begins). Detail: Costa Rica Ley 9234 device PTA pillar. Do not republish a second Costa Rica PTA page under a synonym slug.

    Where “compassionate use” language is doing different work

    • Bolivia: the clinical-studies norm routes continuation into the compassionate-use chapter with per-patient DINAMED authorization — a soft/weak PTA posture that is not Brazil’s pre-trial CEP plan.
    • Guatemala: AM 82-2019 Art. 64 is request-driven toward the sponsor; Art. 65 points at compassionate-use authorization by the DRCPFA. That is not automatic cohort PTA.
    • Honduras: Acuerdo 0256-ARSA-2025 Art. 63 creates a new free-supply mandate and names extension trial or compassionate use as routes — read Art. 63 next to Art. 18 numeral 5’s softer “cuando el patrocinador lo considere” language before you equate Honduras with Brazil.
    • United States / Puerto Rico: 21 CFR 312 Subpart I is permissive expanded access, not a LATAM-style sponsor PTA mandate. Do not paste Subpart I templates into an ANMAT 12792 or Panama Art. 68 file.

    Filing mistakes that look like vocabulary errors

    1. RAEM for an Argentine trial cohort. Wrong instrument, wrong filer, wrong quantity clock.
    2. Calling Brazil PTA “compassionate use” in the CEP cover letter. Brazil already distinguishes post-estudo from uso compassivo and acesso expandido in ANVISA request counts and RDC 38/2013 framing.
    3. Citing repealed PTA bases. Argentina Disp. 6677/2010 (repealed by Disp. 7516/2025), Ecuador AM 0075-2017, Honduras Acuerdo 041-2020, Panama Decretos 1843/2014 and 6/2015 — still appear in vendor decks.
    4. Assuming obligation implies pathway. Costa Rica and Ecuador show mandate without a clean post-trial import article. Mechanism has to be constructed; it is not “file compassionate use.”
    5. Inventing PTA where the map says none. Colombia and Mexico are the usual victims of template overreach.

    Operator checklist before you pick a petition name

    1. Classify the country: binding PTA / weak / none — using the current instrument on the operator map.
    2. Decide whether the patients are trial participants (cohort PTA) or named patients outside that dossier (exceptional / RAEM-style).
    3. Name the authorizing office and article you will put in the work order — not “the agency.”
    4. Confirm whether devices are textually in scope (Costa Rica Art. 53(k), Brazil Art. 37, Chile Art. 111 A, Peru Art. 2.1.36; Ecuador AM 00069-2024 is medicines-oriented).
    5. Appoint the importer of record for the period after the trial import permit lapses.
    6. Size cold chain and pharmacovigilance for the real duration — Brazil’s five-year clock starts at Brazilian commercial availability; Chile’s Art. 111 C has no commercialization endpoint.

    Working on a LATAM post-trial or exceptional-access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you need the instrument, desk, and petition type mapped for a live protocol country list, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    Is compassionate use the same as post-trial access in Latin America?

    Usually no. Post-trial access is continued supply to participants of an authorized trial under a country-specific duty or ethics framework. Compassionate use / exceptional / RAEM-style routes are typically individual-patient pathways that may have nothing to do with a closed or closing trial dossier. Argentina’s Disp. 12792/2016 versus Disp. 4616/2019 is the clearest split; Brazil’s ANVISA assistance channel literally counts compassionate use, expanded access, and post-study supply as separate request types.

    Can I use Argentina’s RAEM for my trial cohort?

    No. RAEM under Disposición 4616/2019 is an individual-patient exceptional import regime with no clinical-trial reference, patient-as-filer rules, and short quantity/validity windows. Cohort post-trial access runs on Disposición 12792/2016, filed by the sponsor before study end.

    Does Brazil treat post-study supply as compassionate use?

    No. Lei 14.874/2024 and Decreto 12.651/2025 create a sponsor PTA duty with a pre-trial CEP plan. RDC 38/2013 lists post-study supply alongside compassionate use and expanded access as assistance programs, but they are different request types. Ministry language calls post-study supply a legal duty, not an expectation.

    Which LATAM countries require post-trial access?

    Ten with binding statutory mandates: Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua and Panama. Three with weak or unassigned duties: Uruguay, Bolivia, Venezuela. Seven with none, including Colombia and Mexico. Read the current instrument — five countries changed frameworks between 2024 and 2026.

    Does Costa Rica’s Ley 9234 cover devices for PTA?

    Yes. Art. 53(k) expressly includes dispositivo alongside medicamento and procedimiento. Duration is “mientras lo requieran” under Art. 28. That is PTA, not a U.S. expanded-access petition — and the statute still does not hand you a dedicated post-trial import article.

    Does Colombia require compassionate use or PTA after a device trial?

    Colombia does not currently mandate post-trial access by statute. Voluntary continuity can still be arranged through the ethics committee, informed consent and general import rules. Do not file a U.S.-style expanded-access template as if INVIMA had a PTA desk for closed studies.

    How should a sponsor pick between PTA and named-patient filings?

    Start from patient status and country instrument. Trial participants in a mandate country → country PTA filing (Argentina 12792, Brazil CEP/ANVISA post-estudo, Panama Art. 68 extension, and so on). Individual patients outside that cohort → the country’s exceptional / compassionate / RAEM-style path, if one exists. Then confirm importer of record, cold chain and PV clocks. Use the ten diligence questions on the PTA operator evaluation page before you sign a work order.

  • How to evaluate a LATAM post-trial access operator: 10 questions to ask

    Most “who does post-trial access in Latin America” shortlists are vendor decks. The diligence question is whether the operator can still import, cold-chain, report safety, and keep patients on product years after database lock — under the instrument that is actually in force in that country.

    I am Julio Martinez-Clark, CEO of bioaccess®. Use these ten questions before you sign a PTA work order. They map to our published LATAM post-trial access operator map and legal architecture pillars. This is not a quote and not legal advice.

    Regulatory questions

    1. Which current instrument and article create the duty? Ask for the citation they will put in the work order: Panama Decreto Ejecutivo 21/2026 Art. 68, Brazil Lei 14.874/2024 Arts. 30–37 and Decreto 12.651/2025, Chile Código Sanitario Art. 111 C (Ley 20.850), Argentina ANMAT Disposición 12792/2016, Peru DS 021-2017-SA Arts. 115–118, Costa Rica Ley 9234 Art. 53(k). If the proposal still cites a repealed Panama Decreto 27/2024 path or treats Argentina Disposición 6677/2010 as if Disp. 7516/2025 erased 12792, stop.
    2. Which office authorizes the continued-supply file? Name the authorizing desk — not “the agency.” Argentina’s post-study import is a Disposición 12792 filing before study end; Brazil’s CEP/ANVISA stack and RDC 38/2013 framing are not interchangeable with Argentina’s cohort route. Wrong office is a multi-month miss.
    3. Does the country mandate PTA for devices at all? Our operator map is explicit: Colombia does not currently mandate post-trial access by statute. Ecuador stays off the “express device mandate” column unless a primary instrument says otherwise. Do not buy a Colombia PTA program that invents a duty the map does not list.

    Import and supply questions

    1. Who is importer of record after the trial import permit lapses? PTA fails when the trial-only import story dies at LPLV. Ask who holds the extension, special-import, or successor authorization, and whether that role is the same entity named as registration holder later.
    2. Can they keep 2–8 °C (or the protocol’s real band) for years past database lock? Multi-year cohort supply is a GDP problem, not a courier problem. Ask for the named depot, excursion SOP, and who owns product that is still on patients after the CRO’s “study close” invoice.
    3. What are the pharmacovigilance onward-transmission clocks? PTA is still a safety file. Ask who receives SAEs from sites, who files to the national authority, and who keeps the SDEA alive when the original CRO work order ends.

    Contract and liability questions

    1. Is there a signed SDEA within a defined window? Our legal-architecture pillar treats ICH E2A/E2F-style safety exchange as part of the PTA stack, not an afterthought. “We will paper PV later” is a red flag.
    2. Which country DPA model is on the table? Argentina Ley 25.326 / AAIP tooling, Brazil LGPD, Chile Ley 21.719 (in force 1 December 2026), Peru DS 016-2024-JUS, and Mexico’s LFPDPPP stack are not one regional template. Ask for the controller/processor labels in local terms.
    3. Is sponsor accession a condition of signature? Product-liability and patient-continuity risk should not sit only on a local operator while the US sponsor stays off the accession page. If the work order is silent, assume the gap is intentional.
    4. What is the patient-continuity run-off if the operator exits? Ask for the written handoff: who imports next, who holds temperature-controlled stock, who tells the investigator and the patient, and which instrument keeps the file open. A PTA proposal without a run-off clause is a brochure.

    Red flags in proposals

    • Reliance on repealed or misnamed instruments (wrong Panama decreto; “Ley 419/2023” folklore; Argentina RAEM sold as the trial-cohort PTA route).
    • Mixing commercial registro / IOR sales with PTA duty as if they were the same file.
    • No named authorizing office, no cold-chain owner, no PV clock, no DPA country, no accession language.
    • A single “LATAM PTA” price that pretends Brazil Art. 37, Chile Art. 111 C, and Panama Art. 68 are one operating system.

    What “operator” has to mean for multi-year PTA

    A LATAM PTA operator is not a one-time importer who can forward a carton. The map pillar’s job is country×instrument clarity; the operator’s job is to keep that instrument executable after the CRO’s study budget ends. That usually means one accountable party for continued import authorization, GDP storage, PV exchange, and patient-facing continuity — not a chain of layered subcontracts that each expire at database lock.

    Compare that to commercial market access. The LATAM registration holder / IOR line and the public LATAM Launch Subscription card answer who holds registro for already FDA-cleared or CE-marked devices. PTA answers who keeps beneficial investigational (or successor) supply moving under a trial-era duty. Mixing the two in one proposal is how diligence fails.

    How to use the answers

    Score each question pass/fail against the country you actually need. Then open the country pillar: Panama Decreto 21/2026 Art. 68, Brazil Lei 14.874, Argentina Disp. 12792/2016, Chile Ley 20.850 / Art. 111 C, Peru DS 021-2017-SA. Market-access registro questions stay on LATAM market access — they do not replace the PTA diligence file.

    If you want bioaccess® to run the diligence against a live protocol country list, send the protocol stage, device risk class, and which countries already have patients on treatment. We will map the instrument, authorizing office, and contract gaps — without inventing a duty the statute does not create.

  • Does Chile’s post-trial access duty transfer to an M&A buyer?

    Yes. The second paragraph of Código Sanitario Article 111 C binds the sanitary-registration holder even when that party never held the provisional-use authorization and even when it acquired the registration afterwards. The free continued-supply duty travels with the Chilean registration by operation of law.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the M&A diligence cut. For the full Art. 111 C analysis, device scope, and ISP role, use Post-trial access in Chile under Ley 20.850 and Código Sanitario Art. 111 C. For the 1 December 2026 DPA refresh under Ley 21.719, use Chile Ley 21.719 PTA DPA refresh.

    Short answer

    Article 111 C, first paragraph, gives the trial patient a right to free continuity of treatment after the study ends, for as long as therapeutic usefulness persists, from (1) the holder of the special provisional-use authorization and, later, (2) the holder of the sanitary registration. The second paragraph is the deal clause:

    “Esta obligación afectará al titular del registro sanitario, aun cuando no haya sido el titular de la autorización provisional o haya adquirido con posterioridad el registro sanitario.”

    Read that literally. An asset purchase that transfers only the Chilean registration — no trial contracts, no site agreements, no sponsor entity — still carries the tail. A licensing deal in which the licensee becomes the Chilean registration holder does the same. Standard reps and warranties rarely surface it, and standard product P&Ls never price it.

    Diligence questions before you buy or in-license

    1. Was any Chilean trial run under an ISP provisional-use authorization for this product, per the public research register ISP must keep under Article 111 A?
    2. How many participants remain on treatment, under what protocol definition of continued benefit?
    3. Who has supplied them since study close, under what import authorization?
    4. Do the indemnities in the purchase agreement acknowledge that the statutory duty to the patient sits with whoever holds the registration — not only with the seller’s representations?

    Breach of Title V is sanctioned under Article 111 G, which routes infractions to Book Ten of the Código Sanitario and to Ley 20.120. Book Ten’s general penalty article allows fines from one-tenth of a UTM up to 1,000 UTM, doubled on recidivism, plus suspension of distribution and use of the products concerned (Código Sanitario Art. 174).

    Devices and open-ended duration

    Devices are expressly in scope through Article 111 A’s “elementos de uso médico,” so the Art. 111 C duty is not a drug-only problem. Duration has no calendar end point: termination turns on loss of therapeutic usefulness under the study protocol, not commercial launch and not a fixed number of years. Brazil’s Lei 14.874/2024 Art. 33 VI permits interruption five years after commercial availability; Chile has a named obligor and no clock.

    Keep the Art. 111 C supply analysis separate from the data-protection contract. Ley 21.719 enters into force on 1 December 2026 and changes how Chilean PTA DPAs should be drafted — that is a companion workstream, not a substitute for the supply diligence above.

    bioaccess® operates regulatory, importadora and PTA architecture for Latin American post-trial programs. For Chile PTA diligence on a live asset or in-license, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Related pillar

    Post-trial access in Chile under Ley 20.850 and Código Sanitario Art. 111 C

    Sources

    • Ley Núm. 20.850, Ministerio de Salud, promulgated 1 June 2015 — https://www.bcn.cl/leychile/navegar?idNorma=1078148
    • Código Sanitario (DFL 725), Article 111 C — https://www.bcn.cl/leychile/navegar?idNorma=5595
    • Chile PTA pillar: https://bioaccessla.com/blog/chile-post-trial-access-ley-20850
    • Chile Ley 21.719 DPA refresh: https://bioaccessla.com/blog/chile-ley-21719-pta-dpa-refresh

  • What is the difference between Argentina cohort PTA and RAEM?

    Disposición 12792/2016 is the sponsor-filed cohort route for post-study continuation of an investigational product. Disposición 4616/2019 (RAEM) is an individual-patient exceptional import regime that never mentions clinical trials. RAEM cannot carry a sponsor cohort.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the short decision cut — not a rewrite of the Argentina pillar. For the full Article 3 dossier, twelve-month clocks, and the Disp. 7516/2025 GCP reset, use Post-trial access in Argentina under ANMAT Disposición 12792/2016.

    Short answer

    Disp. 12792/2016 Disp. 4616/2019 (RAEM)
    What it is Post-study import procedure for a trial cohort Régimen de Accesibilidad de Excepción a Medicamentos
    Filer The sponsor (el patrocinador) The patient (Art. 4(a)); gestor / intermediary prohibited
    Trial nexus Explicit — ANMAT-authorized clinical pharmacology study None
    Product eligibility Investigational product used in the approved study Medicine not registered with ANMAT but registered in an Anexo I country under Decreto 150/92, “destinados a tratar un paciente en particular” (Art. 2(a))
    Authorization clock 12 months per investigator and center (Art. 4), renewable 90 days before Customs (Art. 12); quantity caps 90/180 days (Art. 5)
    Decision speed Operator calendar driven by the eight-document Art. 3 dossier Art. 10: 10 business days first filing, 3 for continuity

    What Disposición 12792/2016 authorizes

    Article 1 of Disposición 12792/2016 establishes the “Procedimiento para la solicitud de importación de la medicación/tratamiento y materiales para el acceso post-estudio.” Article 3 requires the sponsor to file eight documents previo a la finalización del estudio, including the patient list (identity protected), CEI-approved post-study informed consent, the trial autorización, the CEI dictamen for the access plan, medical-director and investigator letters, product/lot detail, and storage habilitación. Article 4 authorizes per investigator and center for twelve months. Article 8 put the instrumento in force the day after its 17 November 2016 publication. It was not repealed by Disp. 7516/2025.

    The substantive supply duty sits beside the procedure. The recitals of 12792/2016 quote Ministry of Health Resolución 1480/2011 §A9 and Código Civil y Comercial Art. 58(j): where an investigational product has been shown beneficial, the sponsor must continue provision until access is guaranteed by another means.

    What RAEM actually is

    Disposición 4616/2019 approves the Régimen de Accesibilidad de Excepción a Medicamentos. It is fast for what it is — Article 10 promises a decision within 10 business days for first-time filings and 3 for continuity — and three of its features make it unusable for a trial cohort:

    1. Product class. Article 2(a) applies to medicines not registered with ANMAT but registered in an Anexo I country under Decreto 150/92, destined to treat un paciente en particular. An unapproved investigational product has no Anexo I registration to lean on.
    2. Filer. Article 4(a) makes the patient the filer and prohibits any gestor or intermediary. A sponsor CRO cannot legally stand in that queue for a cohort.
    3. Clock and quantity. Article 12 gives the authorization 90 days of validity before Customs (AFIP-DGA). Article 5 caps quantities at 90 days of treatment for short courses and all oncology, 180 days otherwise.

    Can a sponsor use RAEM for a trial cohort?

    No. Route the cohort through Disposición 12792/2016 before study close. Keep RAEM for the rare single-patient, registered-elsewhere exceptional case that is not a post-study continuation of an ANMAT-authorized trial. Do not wait until last-patient-last-visit to discover that the 12792 filing window has closed.

    For the four-contract stack that sits around any Argentine PTA filing (SDEA, DPA, product liability, sponsor accession), see The legal architecture of Latin American post-trial access.

    bioaccess® operates regulatory, importadora and depósito functions for LATAM post-trial access. For Argentina PTA feasibility against the current instrument, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Related pillar

    Post-trial access in Argentina under ANMAT Disposición 12792/2016

    Sources

    • ANMAT Disposición 12792/2016 — procedure for post-study import of medication/treatment and materials (Boletín Oficial, 17 Nov 2016)
    • ANMAT Disposición 4616/2019 (RAEM), Boletín Oficial, published 4 June 2019 — https://www.boletinoficial.gob.ar/detalleAviso/primera/208794/20190604
    • ANMAT Disposición 7516/2025, Boletín Oficial, published 9 October 2025, in force 1 December 2025 — https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
    • Argentina PTA pillar: https://bioaccessla.com/blog/argentina-post-trial-access-anmat-disposicion-12792

  • Costa Rica Ley 9234: the clearest express device post-trial access duty in LATAM

    Costa Rica is the clearest express medical-device post-trial access statute in Latin America. Ley 9234 Art. 53(k) obliges free post-study provision of “el medicamento, dispositivo o procedimiento,” and Art. 28 sets duration at “mientras lo requieran.” If your protocol language still talks as if PTA were medicines-only, you are drafting against the wrong country.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the device cut of Costa Rica PTA. For the regional mandate list, use Which LATAM countries mandate post-trial access for medical devices?. For the operator map, use Post-trial access in Latin America: the operator’s map.

    Article 53(k) — what the text actually covers

    Art. 53(k) is not an inference from a medicines chapter. It names medicamento, dispositivo o procedimiento in the free post-study provision duty. That is why Costa Rica sits in the “express device mandate” column on our published map, beside Brazil Art. 37, Chile Art. 111 C, and Peru’s device-reaching Reglamento language — and ahead of jurisdictions that stay silent or medicines-framed.

    For a Class II/III investigational device, that sentence is the planning input: assume free continuation supply is on the table for subjects who still need the intervention after the last protocol visit, unless a lawful exit in the statute applies. Do not wait for a hospital ethics committee to invent the duty for you; put it in the protocol and the budget before first implant.

    Duration under Article 28

    Art. 28’s “mientras lo requieran” is an open clinical need clock, not a neat “database lock + 90 days” commercial habit. Budget, import, and complaint handling have to survive that runway. Compare Brazil’s in-force five-year commercial-availability cap under Lei 14.874 Art. 33 VI, or Argentina’s twin structure of substantive duty plus renewable import authorization under Disp. 12792/2016 — Costa Rica’s duration clause is closer to open-ended clinical need than to a fixed statutory ceiling.

    Open duration is not an invitation to invent infinite liability in a CRO work order. It is a signal to define clinical “still requires,” complaint ownership, and who decides discontinuation when the treating physician says the intervention is no longer needed.

    The planning problem: obligation without a named post-trial import path

    Art. 55 addresses importation in the pre-study / approved-investigation lane. The statute does not hand you a tidy, labeled “post-trial import license” chapter the way some neighbors do with PTA-specific import or ofício mechanics. That gap is the operator issue:

    • Duty: free provision while subjects require the product or procedure.
    • Pathway: not spelled out as a standalone post-trial import track in the same way Brazil RDC 38/2013 or Panama’s import-permit-extension framing appears in our published pillars.

    Sponsors who only paste Art. 53(k) into the protocol and leave logistics blank discover the gap at close-out. Build the import, customs, cold-chain, and complaint path into the PTA work order before first patient — not after the last monitor visit.

    How Costa Rica compares on devices

    Country Device reach Duration signal Operator note
    Costa Rica (Ley 9234) Express: medicamento, dispositivo o procedimiento (Art. 53(k)) “Mientras lo requieran” (Art. 28) Strong text; import pathway must be engineered
    Brazil (Lei 14.874) Art. 37 reaches devices/ATMPs; RDC 38 is the practical import/assistance mechanism for many files Interruption grounds incl. five-year commercial cap (Art. 33 VI) Statute + RDC mechanics
    Chile (Art. 111 C) Express device-capable Código Sanitario duty Open-ended patient need; successor on registro holder Supply + M&A diligence
    Peru (DS 021-2017-SA) Device-reaching Reglamento; ANM/DIGEMID practice for case-by-case route Benefit-linked continuation language Art. 117 document set on the case-by-case path
    Colombia No PTA statute on our published map N/A Do not invent a Colombian PTA duty from INVIMA trial rules

    Use that table for protocol country selection conversations. Do not collapse “express device mandate” into “easy logistics.”

    What to put in the Costa Rica PTA work order

    1. Subject of supply. Device, accessory, procedure support, explant/replacement rules — named, not “investigational product” as a vague bag.
    2. Exit conditions. Map the statutory exits in Art. 53(k) / related articles to protocol language counsel will actually sign.
    3. Import and release path. Even if the statute is thin on post-trial mechanics, the work order must name who files, who holds inventory, and who releases units after database lock.
    4. Complaint and vigilance handoff for units still in subjects after the trial CES.
    5. Sponsor accession. If a CRO or local operator signs operational pieces, the sponsor still owns the statutory duty — put accession in writing (same architecture principle as our legal pillar).
    6. Budget line that survives close-out. PTA that is only a protocol sentence without a cost center dies in finance review the week after LPLV.

    FIH vs commercial registro — keep the tracks apart

    Costa Rica PTA is a trial-aftermath patient duty. It is not a shortcut to commercial registro, and it is not a substitute for ethics and authority authorization to start the investigation. Same rule we publish for Panama, El Salvador, Argentina, and Peru: trial authorization and selling license are different petitions. PTA sits on the trial side until a commercial holder path exists — and even then Chile-style successor problems show why you track who holds what.

    If you are choosing among Costa Rica, Panama, Brazil, and Chile for an early device cohort with a real continuation risk, start from the mandate text, then stress-test import and complaint logistics. bioaccess® will tell you whether the protocol’s PTA paragraph matches Ley 9234 or whether it still reads like a medicines template pasted from another region. Related: Does Panama require post-trial access?, LATAM market access, and the operator map linked above.

  • Chile Ley 21.719 (1 Dec 2026): refresh the PTA DPA before Art. 10 templates go stale

    Chile’s post-trial access duty under Código Sanitario Art. 111 C (inserted by Ley 20.850) is already live. The data-protection contract that sits beside that duty is about to change. Ley 21.719, published 13 December 2024, enters into force on 1 December 2026. A PTA data-processing agreement drafted only to Ley 19.628 Art. 10 will be stale the day that clock flips.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the DPA refresh cut of Chile PTA — not a rewrite of the supply duty. For the patient-facing obligation and the M&A successor clause, use Post-trial access in Chile under Ley 20.850 and Código Sanitario Art. 111 C. For the four-contract stack across Latin America, use The legal architecture of Latin American post-trial access.

    What changes on 1 December 2026

    Ley 21.719 modernizes Chile’s private-data regime. For a multi-year PTA file, the operational change is the cross-border and controller/processor transfer language. Our published legal-architecture pillar already maps the move as Ley 19.628 Art. 10 → Arts. 27–29 under Ley 21.719. That is the drafting target for any Chilean PTA DPA signed now and expected to still be in force after 1 December 2026.

    Do not treat 1 December 2026 as a soft reminder on a shared drive. Treat it as a hard cutover for new signatures and for renewals that will outlive the old Art. 10 template. If your Argentina or Brazil PTA packs already went through a privacy refresh this year, put Chile on the same calendar with a named owner.

    Keep Art. 111 C supply analysis separate from the DPA refresh

    Art. 111 C is a free continued-supply duty that attaches to the provisional-authorization holder and then to the sanitary-registration holder — including a later buyer. That is a patient-right and product-supply problem. The DPA is a personal-data problem: who is controlador, who is encargado, what leaves Chile, and on what contractual terms.

    Mixing the two in one memo is how diligence fails. A buyer can inherit Art. 111 C patients still on treatment and also inherit a DPA that no longer matches the statute. Draft the supply diligence checklist and the DPA checklist as two columns on the same closing binder page so nobody “fixes privacy” by deleting a supply paragraph.

    Drafting to Arts. 27–29 now

    1. Name the roles in Chilean terms. Sponsor as controlador; PTA operator / importer / cold-chain vendor as encargado where that is the real processing pattern. Do not paste a US “business associate” label and hope it maps.
    2. Write the transfer regime to Arts. 27–29, not only to the old Art. 10 carve-outs. If US or EU recipients will see PTA patient data (safety, continuation, logistics), say so and attach the mechanism the new law requires.
    3. Separate health-data sensitivity from commercial logistics fields. Continuation supply needs enough clinical information to treat safely; it does not need a full trial database dump into every vendor mailbox.
    4. Align retention with the open-ended supply clock. Art. 111 C duration is not a neat database-lock plus thirty days. The DPA retention clause has to survive the same runway as the product.
    5. Put audit and sub-processor flow-downs in the operator schedule so a cold-chain or call-center subcontractor cannot outrun the sponsor’s controller duties.
    6. Version the schedule of processing activities when the PTA cohort shrinks or expands. A DPA frozen at first patient in will not describe year-three continuation reality.

    What ISP’s device GCP guide does not fix for you

    Chile’s first-edition device GCP guide (Resolución Exenta N° 341 of 7 April 2026 / related Res. Ex. 2.050 material already cited on the Chile PTA pillar) speaks to Art. 111 A territory and post-participation adverse-event care. It is silent on Art. 111 C’s free continued-supply duty. Silence in a GCP guide does not erase a Código Sanitario article. It also does not draft your DPA. Sponsors who treat the new guide as the full Title V picture still miss both the successor supply clause and the 1 December 2026 privacy cutover.

    Operator checklist before you sign the next Chilean PTA pack

    • Is the DPA template dated against Ley 21.719 Arts. 27–29, or only Ley 19.628 Art. 10?
    • Does the pack separate Art. 111 C supply (who pays, who imports, who holds registro) from privacy (who processes, who transfers)?
    • If an M&A is plausible before PTA ends, does the diligence file list patients still on treatment and the surviving DPA?
    • Are US/EU recipients named with a transfer mechanism that will still be valid after 1 December 2026?
    • Is retention tied to the supply obligation, not to “study close-out”?
    • Does the operator schedule name sub-processors that actually touch identifiers or clinical notes?

    How this sits beside the rest of LATAM

    Brazil’s LGPD, Peru’s DS 016-2024-JUS, and Argentina’s Ley 25.326 / AAIP stack each force the same operator posture: sponsor as controller, operator as processor, written flow-downs, and a transfer story that matches the destination. Chile’s cutover date is simply the next hard calendar event on that list. Use the LATAM post-trial access operator map for country duty comparison; use this page for the Chile privacy refresh only.

    If you are mid-protocol in Chile and the PTA pack still cites only Ley 19.628 Art. 10, rewrite the DPA before 1 December 2026 — and keep Art. 111 C supply on its own page of the binder. For a country-by-country PTA read, start with the operator map and the Chile pillar linked above. Market-access and registro questions stay on LATAM market access; they are not a substitute for the PTA privacy file.

  • Which LATAM countries mandate post-trial access for medical devices?

    Four Latin American jurisdictions textually mandate post-trial access (PTA) for medical devices: Costa Rica (Ley 9234 Art. 53(k)), Brazil (Lei 14.874/2024 Art. 37), Chile (Código Sanitario Art. 111 A → 111 C), and Peru (DS 021-2017-SA Art. 2.1.36). Ecuador’s AM 00069-2024 does not. Argentina’s Disp. 12792/2016 is inferential.

    Most LATAM PTA statutes were drafted for medicines. Device sponsors who assume drug rules apply without reading product-class language understate exposure in four countries and overstate it in others.

    Short answer: which countries mandate device PTA?

    Express textual reach (4): Costa Rica, Brazil, Chile, Peru.

    Inferential / confirm-with-regulator: Argentina (productos y materiales; no dispositivo médico); Panama (Art. 68 “el producto” — confirm import pathway with DNFD).

    Medicines-only among binding PTA countries: Ecuador.

    Ten-country PTA mandate list: Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, and Nicaragua (LATAM PTA operator map).

    Colombia disclaimer: Colombia does not currently mandate post-trial access by statute. When post-trial supply is required, bioaccess® can operate voluntary continuity programs on sponsor request. PTA statutory mandates in LATAM currently apply to Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, and Nicaragua.

    Which jurisdictions expressly cover medical devices?

    Costa Rica — strongest express device language. Ley 9234 Art. 53(k) obliges free post-study provision of “el medicamento, dispositivo o procedimiento que ha sido objeto de investigación,” with enumerated exits. Art. 28 sets duration at “mientras lo requieran.” No other LATAM PTA instrument states device and procedure coverage this plainly (Map hub).

    Brazil — Chapter VI extends to devices and ATMPs. Lei 14.874/2024 Art. 37 applies the post-trial chapter to “produtos e dispositivos médicos” and experimental advanced therapies “no que couber.” Decreto 12.651/2025 Art. 31 speaks of produto sob investigação. Full analysis: Brazil PTA pillar.

    Chile — Art. 111 A pulls devices into Art. 111 C. Código Sanitario Art. 111 A requires the provisional-use authorization for “todo producto farmacéutico o dispositivo médico.” Art. 111 C then binds that authorization holder — and later the sanitary-registration holder — to free continuity “por todo el tiempo que persista su utilidad terapéutica” (Chile PTA pillar). ISP’s April 2026 device GCP guide (Res. Ex. N° 341 / 2.050) cites Art. 111 A but is silent on Art. 111 C; guidance silence does not erase the statute.

    Peru — definitional inclusion. DS 021-2017-SA Art. 2.1.36 defines producto en investigación as “un producto farmacéutico o dispositivo médico.” Título X (Arts. 115–118) operates on that term with no device carve-out (Peru PTA pillar).

    Which mandate countries are silent, inferential, or medicines-only?

    Ecuador — medicines-only. AM 00069-2024 Arts. 80–81 create a sponsor free-supply duty inside a medicines / natural-medicinal-products reglamento. Device exposure there runs through ethics-committee expectations and informed consent, not those articles (Map hub).

    Argentina — inferential. Disp. 12792/2016 Art. 3(f) covers products and “los materiales” that must match the approved study. Dispositivo médico does not appear. Confirm with ANMAT before assuming the cohort import route applies (Argentina PTA pillar).

    Panama — product language; confirm pathway. Decreto Ejecutivo 21/2026 Art. 68 refers to “el producto”; Chapter XIII covers medicines and other products for human health. Device studies fit a fair reading, but sponsors should confirm the import-permit-extension pathway with DNFD. Primary-source verification required for any device-class DNFD circular not already cited on the Panama pillar.

    Guatemala, Honduras, and Nicaragua sit in the ten-country PTA mandate set (Map hub); device-specific textual reach is thinner than the four express jurisdictions and should be verified before protocol lock. Guatemala AM 82-2019 vs AM 206-2021 supersession status remains primary-source verification required.

    What operational gaps remain after a device duty attaches?

    Obligation is not pathway. Costa Rica Art. 53(k) mandates free device provision, but Art. 55 addresses importation only before an approved study begins — no post-trial import route is identified in the statute (Map hub). Brazil Art. 37 is clear, yet RDC 38/2013 speaks of medicamento; build post-close import from the trial’s own authorizations (Brazil pillar).

    Chile’s open-ended “utilidad terapéutica” raises replacement, consumable, explant, and end-of-life questions the statute does not answer — close them in the protocol (Chile pillar). Peru’s duty can mean continued consumables or support for an implanted system with no device-specific carve-out (Peru pillar).

    Before first site activation: classify each country as express / inferential / medicines-only / no PTA statute; quote the device-scope article; name the post-close import mechanism or document that none exists; define device-system continuity in the protocol; appoint an importer of record after trial authorizations lapse.

    Working on a LATAM device PTA program? bioaccess® is a US-headquartered, LATAM-native operator for regulatory, importadora, and 2–8 °C GDP cold-chain functions. Contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Related pillar

    For the full 20-country mandate matrix, cost allocation, and duration comparative — including the ten binding-statute countries and Colombia’s no-PTA framing — read Post-trial access in Latin America: the operator’s map.

    Sources

    • Costa Rica — Ley N.º 9234 (Arts. 28, 53(k), 55): https://documentos.una.ac.cr/bitstream/handle/unadocs/5670/Texto%20Completo%20Norma%209234.pdf?sequence=1&isAllowed=y
    • Brazil — Lei nº 14.874/2024 Art. 37: https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
    • Brazil — Decreto nº 12.651/2025 Art. 31: https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
    • Brazil — ANVISA RDC nº 38/2013: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000038&seqAto=000&valorAno=2013&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
    • Chile — Código Sanitario Arts. 111 A, 111 C: https://www.bcn.cl/leychile/navegar?idNorma=5595
    • Chile — Ley 20.850: https://www.bcn.cl/leychile/navegar?idNorma=1078148
    • Chile — ISP Res. Ex. N° 341 / Res. Ex. 2.050: https://www.bcn.cl/leychile/navegar?idNorma=1223885
    • Peru — DS 021-2017-SA Arts. 2.1.36, 115–118: https://ensayosclinicos-repec.ins.gob.pe/images/Reglamento_de_EC.pdf
    • Ecuador — AM 00069-2024 Arts. 80–81, 95(c): https://www.espoch.edu.ec/wp-content/uploads/2025/10/ac-00069-2024_dic_31_compressed_1-1.pdf
    • Argentina — ANMAT Disposición 12792/2016 Art. 3(f): https://www.boletinoficial.gob.ar/detalleAviso/primera/154162/20161117
    • Colombia — Resolución 2378 de 2008: https://www.ins.gov.co/Normatividad/Resoluciones/RESOLUCION%202378%20DE%202008.pdf
    • LATAM PTA Operator Map: https://bioaccessla.com/blog/latam-post-trial-access-operator-map
    • Brazil PTA pillar: https://bioaccessla.com/blog/brazil-post-trial-access-lei-14874
    • Chile PTA pillar: https://bioaccessla.com/blog/chile-post-trial-access-ley-20850
    • Peru PTA pillar: https://bioaccessla.com/blog/peru-post-trial-access-ds-021-2017-sa
    • Argentina PTA pillar: https://bioaccessla.com/blog/argentina-post-trial-access-anmat-disposicion-12792
    • Panama PTA pillar: https://bioaccessla.com/blog/panama-post-trial-access-decreto-ejecutivo-21-2026