cms.bioaccessla.com

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

Written by

Julio Martinez-Clark

in

,

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

More posts