The Post-Trial Access Trap Medtech Sponsors Ignore In Latin America

By Julio G. Martinez-Clark, CEO, bioaccess

Most medtech study budgets I review end at the same line: last patient out. The final visit closes, the database locks, and the sponsor assumes its duties to participants end with the study. In several Latin American countries, that assumption is wrong. The law can require a sponsor to keep providing the investigational product at no cost to the participant after the trial is over. For a device company, that can mean implants, programming, consumables, and service, sometimes with no fixed end date.

The principle is not new. The 2024 revision of the World Medical Association Declaration of Helsinki says that, before a trial starts, post-trial provisions must be arranged for all participants who still need an intervention identified as beneficial and reasonably safe; exceptions need ethics committee approval, and the provisions belong in the protocol and the consent process.¹ What has changed is how many countries in the region have made that principle binding, most recently Panama in April 2026, and how rarely device sponsors read the text before choosing a country. Latin America is not an outlier. It is ahead of a global curve.

Post-trial access is usually discussed as a drug problem. A device is different. An implant stays in the body and may need programming, batteries, leads, or replacement parts. A diagnostic platform needs cartridges, reagents, software, and calibration. A single-use procedural device leaves nothing behind to maintain. The same rule lands very differently on each, and that is where the trap sits.

What The Rules Actually Say

Brazil has the most detailed regime. Law 14,874 of 2024 devotes a full chapter to continuity of treatment.² Before the trial, the sponsor and investigator file a post-study access plan with the research ethics committee (CEP) (art. 30). At the end, the investigator assesses each participant; free supply, at the sponsor's expense, is required when the product is considered the best therapy and has a more favorable benefit-risk balance than available alternatives (arts. 31 and 32). Supply may stop, with a justification to the CEP, for the participant's decision; cure or a satisfactory alternative; loss of benefit; an adverse reaction that makes continuation unviable in the investigator's judgment; inability to obtain or manufacture the product for duly justified technical or safety reasons if an equivalent or better marketed alternative is offered; five years after commercial availability in Brazil; or availability in the public health network (art. 33). The five-year ground (item VI) was vetoed in 2024; Congress overrode the veto on June 17, 2025, and it was promulgated on July 1, 2025. The chapter is written around medicines, but article 37 applies it to devices "no que couber," to the extent it fits. Decree 12,651 of 2025 restates the sponsor's supply guarantee (art. 31) and keeps existing National Health Council rules in force only insofar as they are compatible with the law and the decree, until the national ethics body issues new ones (art. 39).³ "To the extent it fits" is exactly what the CEP will ask a device sponsor, and the answer belongs in the plan filed before enrollment.

Argentina causes the most confusion. Disposition 12792/2016 of the national regulator, ANMAT, is often cited as the post-trial access rule, but it is an import procedure for post-study medication in clinical pharmacology studies: the sponsor files before the study ends, swears that no cost will fall on the participant, institution, or health coverage, and receives a 12-month authorization.⁴ ANMAT's 2025 good clinical practice rule, Disposition 7516/2025, keeps the same approach for pharmacology studies.⁵ Neither is written for devices. Device studies fall under Disposition 969/1997, which has no explicit post-trial supply clause.⁶ Device sponsors are still covered. Article 58 of the Civil and Commercial Code, in force since Aug. 1, 2015, governs research involving interventions "such as treatments, prevention methods, diagnostic or predictive tests," and item (j) requires that participants be assured access to treatments the research has shown to be beneficial.⁷ It is code-level, not limited to drugs, and expressly reaches diagnostics.

Chile's rule is short and severe. The Sanitary Code title on trials of pharmaceutical products and "elementos de uso médico," added by Law 20,850, requires the holder of the provisional-use authorization, and later the registration holder, to continue treatment at no cost to the patient for as long as its therapeutic usefulness persists, according to the protocol (art. 111 C).⁸ The duty follows the registration, including to a later acquirer. The same title makes the holder liable for research-related harm even if it was unforeseeable, presumes causation once harm is proven, and generally sets a 10-year limitation period from when the harm appears, with a different clock for certain trials run during a declared epidemic or pandemic health alert (art. 111 E).

Peru's regulation, Supreme Decree 021-2017-SA, defines the investigational product to include devices and devotes Title X to post-study access: free availability after participation ends, even if the product is registered, planned before the study, and explained in consent (art. 115).⁹ The criteria include severity, the effect of stopping, lack of satisfactory alternatives in Peru, and a positive benefit-risk balance, and access lasts while there is benefit; if a Ministry of Health program covers the condition, the sponsor supplies until the program can. Access runs through an extension study or a case-by-case authorization from the medicines and devices authority (arts. 116 and 117). A 2023 amendment updated the name of the National Institute of Health's competent office but left Title X unchanged.¹⁰

Costa Rica is the most explicit about devices. Law 9234 of 2014 obliges the sponsor to provide, free of charge after the research concludes, "the medicine, device or procedure" studied, with narrow exceptions: it stops being effective or needed; development is suspended; the treating investigator certifies in a documented decision that it is not indispensable and alternatives exist, with notice to the ethics committee within three business days; or the participant declines (art. 53(k)).¹¹ Article 28 extends the right to preventive, therapeutic, and diagnostic treatments shown to be beneficial, prescribed with the endorsement of the professionals responsible for the participant's care, "mientras lo requieran," for as long as they need them.

Panama is the newest entry. Executive Decree 21 of April 23, 2026, in force on promulgation, regulates the research titles of Law 84 of 2019 and repeals the earlier regulations (arts. 104 and 105).¹² Article 68 requires investigators and sponsors to ensure participants access to the product, if its clinical or public health benefit was demonstrated, until it is commercialized in Panama, and to request an extension of the study's import permit for the participants' exclusive use through the post-research phase. The extension is not automatic. Exceptional cases go to the research bioethics committee, which decides the mechanism under criteria defined in advance, and the sponsor must have agreements reflecting its intention to commercialize in the country. Article 68 does not itself say access is free or define what services it includes. It says "product" rather than "medicine" but does not name devices; the decree's chapter on investigational products is broad, so I read devices as covered by inference until a committee says otherwise.¹² The earlier 2024 definition was medicine-specific.¹³ Commercialization in Panama is the stated ordinary endpoint, not the only one, so a sponsor that never plans to sell there should raise its exit with the committee early.

Mexico and Colombia are lighter, for now. Official Standard NOM-012-SSA3-2012, which covers devices, makes the intervention free during the study, requires a fund guaranteeing continuity of treatment and compensation, and requires the investigator to provide what is needed to continue care and avoid effects from stopping at the end of the study (sections 4.16, 5.7, 5.14, and 11.2.2).^14,15 NOM-012 does not expressly impose a general obligation to keep supplying the product after the trial; it describes a safe exit, which still needs money behind it. In Colombia, Resolution 8430 of 1993 contains no express post-trial supply clause, though it makes the sponsor or institution responsible for research-related harm (arts. 13, 15, and 60).¹⁶ The Ministry of Health's 2026 draft resolution would add a post-study benefits plan, framed as conditional and not indefinite, ending when the intervention is approved and available in Colombia or another adequate therapy exists (arts. 9(25) and 39).¹⁷ As of October 2026 I found no enacted version, but sponsors closing studies in 2027 or later should read it now.

A Global Norm, Written Into Law Early

The direction everywhere is the same: from soft expectation to planned obligation. Helsinki's 2013 text said sponsors, researchers, and host country governments "should make provisions" for post-trial access;¹⁸ the 2024 revision says provisions "must be arranged" in advance, delivered by sponsors and researchers themselves, healthcare systems, or governments.¹ The 2016 Council for International Organizations of Medical Sciences (CIOMS) guidelines treat continued access to interventions of significant benefit as a universal planning duty and name the same exits Latin American laws use.¹⁹ Binding rules elsewhere are lighter. The EU Clinical Trials Regulation requires the protocol to describe post-participation care where the trial makes it necessary, without imposing continued supply.²⁰ India's 2019 rules require free post-trial access for drugs under defined conditions.²¹ The United States relies on extension studies and FDA expanded access.²² The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard frames continued access as a shared responsibility settled before the trial and has a separate framework for significant-risk devices.²³

Seen this way, the countries above are early adopters: They wrote the Helsinki and CIOMS principles into law with named triggers, decision makers, and exits. That helps sponsors, because written rules can be planned and costed. A plan built to Helsinki and CIOMS is most of the way there.

Why Devices Make It Harder

Implantables. The participant keeps the implant regardless. The question is who pays to keep it working: programming, external units, batteries, replacement components, revision or explant, and clinician time. Chile's and Costa Rica's wording has no built-in end date, and Panama's ordinary endpoint is commercialization in the country. Brazil's stopping grounds are the closest thing to a sunset clause and still require a justification to the CEP. Which of these items the law strictly requires is not spelled out uniformly; treat them as cost scenarios to plan for, not a statutory list.

Diagnostics. A beneficial diagnostic helps only if someone keeps the system running: reader, software license, cartridges, reagents, calibration, and service. Argentina's code expressly reaches diagnostic tests.

Single-use and procedural devices. The exposure is smaller but not zero. If a participant later needs the procedure again, a strict reading of Peru's or Costa Rica's rules could point to supplying the device again. Put the question to the ethics committee and get the answer in writing before enrollment.

Build The Exit Before Patient One

By database lock, the obligations are already written into approved documents. Brazil requires the plan to be filed before the trial,² Peru requires the consent form to explain post-study availability,⁹ and Helsinki requires both protocol and consent to cover it.¹ An access promise must match the protocol, budget, and supply arrangements. Before choosing a country and enrolling the first participant, answer these questions in writing:

1. Does the law put the duty on the sponsor, investigator, or registration holder, and does it reach devices expressly, by inference, or only "to the extent it fits"?
2. Who qualifies, who decides, and what exactly is provided: device, accessories, consumables, software, service, or follow-up visits?
3. What ends the obligation in each country, and is the registration and commercialization plan realistic enough to reach that exit?
4. What does continued access cost per participant per year, and is it in the budget, stated as no cost to the participant, institution, or health coverage?
5. Who holds and renews import and dispensing permits after close-out? Argentina's authorizations last 12 months,⁴ Brazil requires prior authorization,² and Panama requires a permit extension.¹²
6. Do supply, software, service, and site contracts cover post-trial units and visits and survive a change of control? Chile's duty follows the registration to an acquirer.⁸
7. Is insurance aligned? Costa Rica requires liability cover for at least two years after participation,¹¹ Mexico lets study insurance back its fund,¹⁴ and Chile's limitation period outlasts most budgets.⁸ A liability policy does not pay for product supply.
8. Are protocol, consent form, budget, and site contracts consistent with each other, and how do participants move to regular care if the device is approved, withdrawn, or discontinued?

None of this is a reason to avoid Latin America. The region's speed and patient access are real, and these rules ask for what Helsinki and CIOMS already expect of every sponsor. Latin America made it binding first. The trap is not the obligation. It is discovering it after the last patient visit, when the commitment is already in the participant's signed consent.

Author’s note: This column is general information, not legal or regulatory advice; sponsors should confirm requirements with local regulatory counsel. Law reviewed through October 2026.

References

1. World Medical Association. (2024, October). WMA Declaration of Helsinki: Ethical principles for medical research involving human participants (paragraphs 22 and 34). World Medical Association. https://www.wma.net/policies-post/wma-declaration-of-helsinki/
2. Presidência da República (Brazil). (2024, May 28). Lei nº 14.874, de 28 de maio de 2024: Dispõe sobre a pesquisa com seres humanos e institui o Sistema Nacional de Ética em Pesquisa com Seres Humanos (Chapter VI, arts. 30 to 37; art. 33, VI promulgated July 1, 2025). Planalto. https://www.planalto.gov.br/ccivil_03/_Ato2023-2026/2024/Lei/L14874.htm
3. Presidência da República (Brazil). (2025, October 7). Decreto nº 12.651, de 7 de outubro de 2025 (regulates Lei nº 14.874/2024; arts. 31 and 39). Câmara dos Deputados, Legislação Informatizada. https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
4. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Argentina. (2016, November 16; published November 17). Disposición 12792/2016: Procedimiento para la importación de medicación, tratamiento y materiales para el acceso post-estudio en estudios de farmacología clínica. InfoLEG. https://servicios.infoleg.gob.ar/infolegInternet/anexos/265000-269999/267853/norma.htm
5. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Argentina. (2025, October 8). Disposición 7516/2025: Régimen de Buenas Prácticas Clínicas para estudios de farmacología clínica (Annex II, §2.7.6; Annex III, section 6; dated October 8, published October 9, effective December 1, 2025). Boletín Oficial. https://www.argentina.gob.ar/normativa/nacional/disposicion-7516-2025-418573
6. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Argentina. (1997). Disposición 969/1997: Régimen de estudios clínicos de tecnología médica (as amended by Disposición 6550/2008). Argentina.gob.ar. https://www.argentina.gob.ar/normativa/nacional/norma-42205/actualizacion
7. Congreso de la Nación Argentina. (2014). Código Civil y Comercial de la Nación, Ley 26.994 (art. 58; in force August 1, 2015 under Ley 26.994 art. 7 as amended by Ley 27.077). InfoLEG. https://servicios.infoleg.gob.ar/infolegInternet/anexos/235000-239999/235975/norma.htm
8. Ministerio de Salud (Chile). Código Sanitario, DFL 725 (Book IV, Title V, arts. 111 A to 111 G, added by Ley 20.850). Biblioteca del Congreso Nacional de Chile, LeyChile. https://www.bcn.cl/leychile/navegar?idNorma=5595
9. Ministerio de Salud (Peru). (2017, June 28). Decreto Supremo N.° 021-2017-SA: Aprueban Reglamento de Ensayos Clínicos (art. 2, art. 40(p), Title X arts. 115 to 118, Annex 4). Plataforma del Estado Peruano. https://www.gob.pe/institucion/minsa/normas-legales/189280-021-2017-sa
10. Ministerio de Salud (Peru). (2023, October 18). Decreto Supremo N.° 028-2023-SA: Decreto Supremo que modifica e incorpora diversos artículos en el Reglamento de Ensayos Clínicos. El Peruano. https://busquedas.elperuano.pe/dispositivo/NL/2226139-2
11. Asamblea Legislativa (Costa Rica). (2014, April 22). Ley N.° 9234, Ley Reguladora de Investigación Biomédica (arts. 28, 31, and 53(k)). Sistema Costarricense de Información Jurídica (SCIJ). https://www.pgrweb.go.cr/scij/Busqueda/Normativa/Normas/nrm_texto_completo.aspx?param1=NRTC&nValor1=1&nValor2=77070&nValor3=96424&strTipM=TC
12. Ministerio de Salud (Panama). (2026, April 23). Decreto Ejecutivo N.° 21 de 23 de abril de 2026, Que reglamenta los Títulos III y IV de la Ley 84 de 14 de mayo de 2019, que regula y promueve la investigación para la salud y establece su rectoría y gobernanza (arts. 68, 104, and 105). Gaceta Oficial Digital No. 30510-C. https://www.minsa.gob.pa/normatividad/decreto-ejecutivo-ndeg-21-jueves-23-de-abril-2026-que-reglamenta-los-titulos-iii-y-iv
13. Ministerio de Salud (Panama). (2024, May 10). Decreto Ejecutivo N.° 27 de 10 de mayo de 2024, que reglamenta la Ley 419 de 1 de febrero de 2024 (art. 2, item 3). Gaceta Oficial Digital No. 30028-C. https://www.minsa.gob.pa/sites/default/files/general/decreto_ejecutivo_27_de_10_de_mayo_de
    _2024.pdf
14. Secretaría de Salud (Mexico). (2013, January 4). Norma Oficial Mexicana NOM-012-SSA3-2012, Que establece los criterios para la ejecución de proyectos de investigación para la salud en seres humanos. Diario Oficial de la Federación. https://dof.gob.mx/nota_detalle.php?codigo=5284148&fecha=04/01/2013
15. Secretaría de Economía (Mexico). NOM-012-SSA3-2012 (status: vigente; last systematic review March 21, 2018). Plataforma de Normalización. https://platiica.economia.gob.mx/normalizacion/nom-012-ssa3-2012/
16. Ministerio de Salud (Colombia). (1993, October 4). Resolución 8430 de 1993: Por la cual se establecen las normas científicas, técnicas y administrativas para la investigación en salud. Compilación Jurídica del Invima. https://normograma.invima.gov.co/compilacion/docs/resolucion_minsalud_r8430_93.htm
17. Ministerio de Salud y Protección Social (Colombia). (2026). Proyecto de resolución por la cual se establecen los requisitos y condiciones administrativas para la investigación relacionada con la salud con seres humanos en Colombia y se deroga parcialmente la Resolución 8430 de 1993 (second public consultation draft, July 29 to August 4, 2026; arts. 9(25) and 39). Hosted by the Asociación Colombiana de Investigación Clínica (ACIC). https://aciccolombia.org/wp-content/uploads/2026/07/Proyecto-de-Resolucion-Investigacion-en-Salud-para-Publicar-segunda-consulta.pdf
18. World Medical Association. (2013, October). WMA Declaration of Helsinki: Ethical principles for medical research involving human subjects (paragraph 34). World Medical Association. https://www.wma.net/policies-post/wma-declaration-of-helsinki/doh-oct2013/
19. Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization. (2016). International ethical guidelines for health-related research involving humans (Guideline 6: Caring for participants' health needs). CIOMS. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
20. European Parliament and Council of the European Union. (2014, April 16). Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Annex I, section D, point 17(ae), protocol content on care of subjects after their participation has ended). EUR-Lex. https://eur-lex.europa.eu/eli/reg/2014/536/oj
21. Ministry of Health and Family Welfare (India). (2019, March 19). New Drugs and Clinical Trials Rules, 2019 (rule 2(1)(cc) and rule 27). Central Drugs Standard Control Organization. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/new_DC_rules/NEW%20
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22. U.S. Food and Drug Administration. 21 CFR Part 312, Subpart I: Expanded access to investigational drugs for treatment use (§§ 312.300 to 312.320). Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-I
23. Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center). Post-trial responsibilities: Principles of post-trial continued access to an investigational product; Framework of responsibilities for investigational medicines and for investigational significant risk devices (Guidance Document Version 1.2, December 6, 2017). MRCT Center. https://mrctcenter.org/project/post-trial-responsibilities/

About The Author:

Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the Global Trial Accelerators podcast. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).