Chile's Easy Market Ends In 2028

By Julio G. Martinez-Clark, CEO, bioaccess

For years, Chile has occupied a strange position in Latin American medtech strategy. It was sophisticated, stable, commercially attractive, and comparatively easy to enter. For many medical device manufacturers, Chile was the market where a good distributor relationship could move faster than a formal regulatory strategy.

That era now has an expiration date.

In 2021, I wrote in Med Device Online that Chile was “currently Latin America’s easiest market” but asked: for how long? At that time, only four categories — contraceptives, gloves, needles, and syringes — required mandatory registration with Chile’s Instituto de Salud Pública (ISP), while most other medical devices could enter through a distributor and importer-of-record model without full ISP sanitary registration.¹ Chile’s new Decree No. 25 answers the question. The country is no longer simply “easy.” It is transitioning.

The Old Chile Assumption Is Now Outdated

The old Chile assumption was simple: unless a device fell into one of the few mandatory categories, the manufacturer could prioritize distributor selection, import logistics, provider relationships, and post-sale support. Voluntary ISP review still had commercial value, but it was not the universal gate to market access.

That model was always vulnerable to reform. Chile’s medical device regulation already had the legal machinery for progressive expansion. Decree Supreme No. 825, the regulation for products and elements of medical use, states that covered medical devices may only be manufactured, imported, marketed, or distributed in Chile if they have the applicable conformity-verification certificate.² Earlier decrees had already used that structure for specific categories, including sterile hypodermic needles and syringes.³

The difference now is scale. On March 19, 2026, Chile published Exempt Decree No. 25 in the Diario Oficial (Núm. 44.404, CVE 2781436), incorporating 39 numbered medical device and in vitro diagnostic (IVD) types into the sanitary control regime established by Article 111 of the Chilean Health Code and Decree Supreme No. 825.⁴ ISP’s announcement described the products as higher-risk and widely used in health services associated with ministerial programs, and stated that conformity verification will be performed by ISP through review of documents supporting quality, safety, and performance.⁵

For manufacturers, the practical message is clear: a market that once rewarded speed through distribution now requires portfolio-level regulatory planning.

The First Deadline Is March 2028

The decree does not regulate every device at once. It creates a phased transition. That matters because the first group contains many products that are clinically important, commercially significant, or difficult to replace quickly.

The 24-month group (13 numbered types in Artículo primero transitorio) includes cardiovascular implants and catheters, heart valves, cochlear implants, orthopedic and soft-tissue implants, copper intrauterine devices, insulin infusion pumps and accessories, and blood bags.⁴ Because the decree was published on March 19, 2026, that first transition period ends on March 19, 2028.

The 36-month group includes imaging, radiotherapy, dialysis, ventilation, extracorporeal circulation, electrosurgical, ophthalmic, continuous glucose monitoring, CPAP/BPAP, sterilization, oncology software, and several IVD categories.⁴ That second transition period ends on March 19, 2029.

The natural reaction is to see those dates and assume there is time. That is the first mistake.

The Missing Instruction Manual Is The Real Clock

The most important operational detail in the decree is not the list of products. It is the filing sequence.

Decree No. 25 gives ISP up to 12 months from publication to issue the technical instruction for conformity verification. It also states that manufacturers, importers, and distributors may request voluntary conformity verification before the decree becomes mandatory, but only once the corresponding technical instruction has been issued.⁴ In other words, the 24-month transition period does not necessarily mean manufacturers have 24 months of usable filing time.

If the technical instruction appears close to the 12-month deadline, manufacturers in the first transition group could have roughly one year to interpret the requirements, assign ownership, assemble documentation, translate files, close standards gaps, coordinate with Chilean partners, submit, respond to questions, and obtain registration.

That is a compressed campaign, not a comfortable runway.

The problem becomes sharper for manufacturers with multiple affected products. A company with stents, catheters, heart valves, and implantable accessories cannot treat the Chile transition as one filing. It needs a portfolio triage model: which products are active, which models should be rationalized, which variants can be grouped, which files are complete, and which products justify the work.

Registration Strategy Now Comes Before Distribution Strategy

Chile’s older market entry model made distributor selection the first strategic move. The new model makes regulatory ownership and portfolio readiness just as important.

The decree states that after the applicable transition dates, the covered products may only be manufactured in Chile, imported, marketed, or distributed if they have the required conformity verification, which the decree defines as ISP sanitary registration.⁴ That changes the commercial leverage in the market. If a distributor is handling importation but the manufacturer has not mapped who will own the Chile file, who will maintain it, who will manage modifications, and who will preserve continuity if the relationship changes, then the manufacturer is building regulatory risk into the sales channel.

This is not only a local compliance issue. It is a regional market access issue. Many manufacturers use Chile as an early Latin American entry point because it offers a stable business environment, respected clinicians, and access to private providers. If Chile becomes harder to enter, the company’s regional launch sequence changes.

The old question was: can the distributor import and sell? The new question is: can the manufacturer maintain registration-backed market access after the transition? A clinical trial authorization or investigational import route is a different file from this commercial registration. It should not be treated as 2028 commercial cover.

The Standards Burden Is Not Generic

Decree No. 25 also moves Chile toward a more explicit standards-based review. It identifies general standards such as NCh ISO 16142/1, NCh ISO 16142/2, NCh ISO 13485, and NCh ISO 14971, and it lists product-specific standards for the 39 categories.⁴ These references matter because they turn Chilean registration preparation into a technical file readiness exercise, not just a local formality.

That aligns with existing ISP guidance. ISP’s guide on essential principles of safety and performance says medical devices and IVDs should achieve the performance intended by the manufacturer and should be designed and manufactured so they are suitable for their intended use under normal conditions, with risks acceptable in relation to patient benefit.⁶ The same guide emphasizes that devices must be accompanied by information in castellano for identification, safety, and performance, and that instructions for use should be easy for the intended user to understand.⁶

For some manufacturers, the documentation already exists because the product has gone through FDA, EU MDR, MDSAP, ISO 13485, or other rigorous review. But existing documentation is not the same as a Chile-ready dossier. A product, family, group, or system filing may not align neatly with Chile’s registration grouping expectations. Labels may need Spanish updates. Legacy devices may have gaps because they were commercialized before current documentation expectations matured.

This is where manufacturers should avoid a common mistake: waiting for ISP’s technical instruction before doing any work. As of late August 2026, that instruction has not been issued. The final filing format is not available yet, but the strategic work is available now.

Chilean Documentation Is Already Operational

Even before the new technical instruction is issued, manufacturers can see the type of operating discipline Chile expects.

ISP’s DDM-001 instruction asks applicants to identify the company, legal representative, technical responsible professional, device name, model codes, manufacturer, sterilization status, and supporting certificates. It also asks that tables describing multiple models include names and brief descriptions of the differentiating characteristics in Spanish.⁷ The related ISP form states that background materials in a language other than Spanish should include a simple translation under sworn declaration.⁸

ISP’s acquisition guide for health institutions also shows why this is not just a filing exercise. For low-risk devices, it recommends requesting labels and user manuals in castellano, and its annexes list label and user manual content such as intended use, storage conditions, warnings, precautions, side effects, troubleshooting, technical service information, and reuse procedures where applicable.⁹

That is the bridge between regulation and commercialization. The same documentation that supports registration also supports hospital purchasing, user training, safe use, and post-sale support.

Postmarket Obligations Are Part Of The Transition

The ISP announcement about Decree No. 25 specifically notes that the new regulation provides a legal framework to support ISP’s postmarket surveillance actions for medical devices.⁵ Manufacturers should take that seriously.

Chile already has technovigilance infrastructure. ISP’s 2026 procedure for enrolling manufacturers, importers, and distributors in the National Technovigilance Network states that companies must first complete the company registration process and device list before enrolling.¹⁰ ISP adverse event form instructions also emphasize complete device identification information, including lot, model, series, manufacturer, and intended use, and warn against generic descriptions such as “catheter,” “valve,” or “screw.”¹¹

That matters because the 2026 decree brings high-risk, technically complex products into a more formalized regime. Registration strategy cannot stop at approval. Manufacturers need a Chile-specific postmarket model: who receives complaints, who reports incidents, who monitors field actions, who maintains product traceability (Decreto Exento 63 of September 6, 2022, Diario Oficial September 17, 2022, Núm. 43.355, CVE 2188182, which approves Norma Técnica N° 226), and who keeps the local file synchronized when the global product changes.

How Manufacturers Should Triage Now

The right response is not panic. It is disciplined triage.

First, manufacturers should map the decree against the current Chile portfolio. The question is not only whether a device category is listed. It is whether each model, accessory, software module, kit, or family currently sold in Chile falls inside the decree’s scope and transition group.

Second, manufacturers should rank products by commercial necessity. Some legacy stockkeeping units may not justify registration. Others may be essential because they anchor a hospital relationship, support a broader platform, or drive consumables revenue. Registration planning should follow commercial value, not simply the order in which documents are easiest to retrieve.

Third, companies should assess technical file readiness before the ISP instruction arrives. The decree already signals quality, safety, performance, risk management, quality management, and product-specific standards. Waiting until the instruction is published to discover missing risk files, obsolete certificates, weak Spanish labeling, or incomplete accessory documentation wastes the only runway that matters.

Fourth, manufacturers should define local responsibility. Who will file? Who will maintain the registration? Who will manage modifications? Who will respond to ISP questions? Who will support postmarket vigilance? If the answer is “the distributor,” the manufacturer should still decide whether that structure protects long-term commercial flexibility.

Fifth, companies should budget for a wave, not a one-off filing. Chile’s reform does not create a single registration event. It creates a multiyear regulatory conversion of the country’s most important medical device categories. Manufacturers should treat it as a portfolio program with governance, timelines, document owners, and escalation rules.

What I Got Right And Wrong In 2021

In 2021, I got the direction right. Chile was not going to remain an unusually open market forever. At the time, Ley de Fármacos II was the legislative vehicle many of us were watching. The instrument that actually landed is different: Decree No. 25, issued by the Ministry of Health and implemented through ISP and ANDIM.

I also understated the eventual scope. The old mandatory list was short. Chile has now jumped to 39 numbered types, including software as a medical device and IVDs. The “for how long?” answer is no longer theoretical. It is March 19, 2028 for the first wave and March 19, 2029 for the second.

The piece I underweighted in 2021 was the instruction gap. A two-year transition looks generous until the agency has up to one year to write the how-to, and early filing is gated on that how-to. That is why manufacturers should not wait for the final instruction to begin portfolio work.

Chile is still a serious market. It is still commercially attractive. It still has a distinctive regulatory culture and commercial logic. What changed is that Chile is no longer the Latin American market a manufacturer can enter for listed types without a sanitary registration strategy. The easy years were 2010 to 2026. The compressed years are 2027 and 2028. Map the catalog now.

References:

1. 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
2. Ministerio de Salud de Chile, Decreto Supremo N° 825, Reglamento de Control de Productos y Elementos de Uso Médico, https://www.bcn.cl/leychile/navegar?idNorma=141005
3. Ministerio de Salud de Chile, Decreto Exento N° 1.887, “Incorpora al sistema de control... agujas hipodérmicas estériles... jeringas hipodérmicas estériles,” https://www.bcn.cl/leychile/navegar?idNorma=268837
4. 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
5. Instituto de Salud Pública de Chile, “ISP informa sobre nueva normativa que regula 39 dispositivos médicos incluidos dispositivos médicos de diagnóstico in vitro,” https://www.ispch.gob.cl/noticia/isp-informa-sobre-nueva-normativa-que-regula-39-dispositivos-medicos-incluidos-dispositivos-medicos-de-diagnostico-in-vitro/
6. Instituto de Salud Pública de Chile, “Guía de Principios Esenciales de Seguridad y Desempeño para Dispositivos Médicos, incluidos los Dispositivos Médicos de Diagnóstico In Vitro,” https://www.ispch.cl/sites/default/files/Guía de Principios Esenciales de Seguridad y Desempeño DM Y DMDIV.pdf
7. Instituto de Salud Pública de Chile, “Instructivo Form DDM-001,” https://www.ispch.cl/sites/default/files/INSTRUCTIVO FORM DDM-001.pdf
8. Instituto de Salud Pública de Chile, “Formulario SDM/001 — Revisión de los antecedentes que acompañan al dispositivo médico,” https://www.ispch.cl/sites/default/files/Formulario SDM 001.doc
9. Instituto de Salud Pública de Chile, “Guía para la adquisición de dispositivos médicos en las instituciones de salud,” https://www.ispch.cl/sites/default/files/1_Guia_para_la_Adquisicion_de_Dispositivos_Medicos
   _en_las_Instituciones_de_Salud.pdf
10. Instituto de Salud Pública de Chile, “Inscripción de Empresas Fabricantes, Importadoras o Distribuidoras de Dispositivos Médicos a la Red Nacional de Tecnovigilancia,” https://www.ispch.cl/wp-content/uploads/prestaciones/2110214/9500000.pdf
11. Instituto de Salud Pública de Chile, “Instrucciones de llenado del formulario ANDID/006,” https://www.ispch.cl/wp-content/uploads/2021/03/Instructivo-Formulario-ANDID-006.pdf

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).