From Regulatory Approval to Healthcare Value: MedTech’s New Agenda in Latin America

José Luis Cárdenas Tomažič / Carmen Polanco L.

Adapted from the Spanish column originally published in El Economista on Septermber 17th, 2026 (Del control sanitario al valor sanitario: la nueva agenda de MedTech en América Latina)

Medical technology has gained ground almost silently. The global medical device market grew from approximately USD 150 billion in 2000 to nearly USD 675 billion in 2024. In less than 25 years, it more than quadrupled in size and became a decisive component of healthcare delivery.

This universe encompasses everything from a syringe, thermometer, or diagnostic test to continuous glucose monitors, implants, pacemakers, robotic surgery, clinical software, and platforms capable of three-dimensionally reconstructing the heart’s electrical activity. Medical devices are no longer merely supplies or supporting equipment. They influence when a disease is detected, how an intervention is performed, how long a hospitalization lasts, and ultimately the outcomes achieved by patients.

Mexico illustrates the industrial expansion accompanying this phenomenon. Its medical device exports increased from USD 10.7 billion in 2020 to USD 20.6 billion in 2025, considering the 138 tariff classifications identified by the industry as strategic. The country remains Latin America’s leading exporter and ranks among the world’s top eight exporters of medical devices.

Yet MedTech is far more than an export industry. Its growing clinical influence raises a question that Latin America is only beginning to address: how do we distinguish between technologies that meet the conditions for commercialization and those that genuinely create greater value for patients, providers, and healthcare systems?

Regulatory Control Establishes the Floor, Not the Value

Not all medical devices are necessarily subject to individual regulatory registration. Requirements depend on the jurisdiction, product category, risk classification, and applicable regulations. Depending on the country and the technology involved, regulatory oversight may take the form of registration, notification, authorization, certification, conformity assessment, or recognition of an evaluation performed by another regulatory authority.

For this reason, it is more accurate to speak of a regulatory floor. That floor seeks to ensure compliance with safety, quality, and performance requirements. It is indispensable for protecting patients, but it does not determine which of several approved alternatives produces better outcomes, is better suited to a hospital’s capabilities, or delivers the lowest total cost over its useful life.

This distinction is particularly important in MedTech. Unlike pharmaceuticals, medical devices often involve learning curves and a greater degree of operator dependency. Their performance may be influenced by infrastructure, training, interoperability, maintenance, software updates, and the availability of spare parts or consumables. Value does not reside solely in the product itself; it also depends on the healthcare process into which it is integrated.

A technology with a low initial purchase price may ultimately prove expensive if it remains underutilized because of inadequate training, requires frequent repairs, or experiences operational disruptions due to shortages of supplies. Conversely, a more expensive option may generate savings if it reduces complications, repeat procedures, hospital length of stay, or workforce burden.

A systematic review of medical equipment procurement in low- and middle-income countries cited estimates suggesting that between 40% and 70% of equipment was either broken, non-functional, or unsuitable for its intended purpose. Among the identified causes were incomplete costing assessments and insufficient consideration of maintenance and training requirements. Purchasing at a lower price, therefore, does not always mean purchasing efficiently.

An International Conversation That Has Already Changed

In the United States and the European Union, the discussion has evolved beyond initial approval and now focuses on managing technologies throughout their entire lifecycle. The agenda increasingly incorporates the quality of clinical evidence, real-world data, traceability, interoperability, cybersecurity, and post-authorization change management.

This shift is particularly relevant for software and artificial intelligence-enabled devices. These technologies can be updated frequently, modify their algorithms, or perform differently depending on patient populations and clinical settings. A pre-market evaluation does not necessarily capture their subsequent evolution or all their effects in real-world practice.

In Europe, Regulation (EU) 2017/745 strengthened risk-based classification, clinical evidence requirements, post-market surveillance, and unique device identification. Regulation (EU) 2021/2282 further established a framework for joint clinical assessments. For selected Class IIb and III devices, as well as Class D in vitro diagnostics, Implementing Regulation (EU) 2025/2086 introduced procedures, formats, and expert participation rules for such assessments.

The conceptual distinction is fundamental. Regulatory oversight asks whether a technology meets the requirements to enter the market. Comparative assessment asks what it contributes relative to available alternatives, for which patients, on which outcomes, and under what conditions of use. The United States and Europe have not resolved all these tensions, but they are already debating how technologies should be compared, monitored, financed, and managed throughout their lifecycle. Much of Latin America remains focused primarily on the point of market entry.

Latin America Is Advancing at Different Speeds

The regional landscape shows significant progress, but it does not reveal a single leader. Strengths and gaps vary depending on the dimension being analyzed.

Brazil updated its framework through ANVISA Resolution RDC 751/2022, which regulates risk classification, notification and registration pathways, and labeling and instructions-for-use requirements. The country combines institutional scale, regulatory maturity, and experience in health technology assessment within healthcare facilities.

Mexico has advanced through a modernization and regulatory convergence agenda. Its abbreviated regulatory pathway allows COFEPRIS to rely on assessments conducted by reference regulatory authorities while retaining responsibility for the final decision. In June 2026, the agency published guidance systematizing the requirements applicable to equivalence agreements and the abbreviated pathway. The next step is to connect this modernization effort with value-based adoption, both in public procurement and provider decision-making.

Colombia continues to rely primarily on Decree 4725 of 2005 and has developed important technovigilance capabilities. Argentina, through ANMAT Provision 64/2025, incorporated the MERCOSUR Technical Regulation on Medical Device Registration. In both cases, the challenge is to connect market-entry controls with adoption decisions that consider the complete lifecycle of technologies.

Chile significantly expanded the range of products subject to regulatory oversight through Exempt Decree No. 25 of 2026 issued by the Ministry of Health. The regulation incorporated 39 medical devices and in vitro diagnostic products, including implantable products and oncology imaging software. This represents a major step forward, although a more comprehensive framework for traceability, assessment, and evidence generation remains pending.

The regional pattern is clear: countries have invested far more effort in defining how a technology enters the market than in determining how its value should be measured once it becomes available.

A Level Playing Field Built on Value

Health technology assessment in Latin America developed primarily around pharmaceuticals. Medical devices have occupied an intermediate space: they are too heterogeneous for pharmaceutical methodologies to be applied automatically, yet they are often reduced to technical specifications and price comparisons. Their learning curves, incremental improvements, operator dependency, and shorter innovation cycles require methodologies specifically adapted to their characteristics.

Bridging this gap requires a MedTech-specific value framework built around four inseparable dimensions:

1. Clinical Value: Safety, effectiveness, diagnostic accuracy, reduction of complications, and improved therapeutic response.

2. Patient and System Outcomes: Quality of life, autonomy, continuity of care, avoided hospitalizations, and more timely access to healthcare. [Columna_Me…ario_LATAM | Word]

3. Operational Impact: Learning curve, training requirements, maintenance, interoperability, procedure times, and utilization of installed capacity.

4. Total Cost of Ownership: Installation, consumables, updates, support, repairs, replacements, continuity of supply, and costs generated or avoided throughout the product lifecycle.

This four-dimensional value framework should guide public procurement, coverage decisions, and hospital adoption. It does not seek to replace regulatory oversight or introduce a new market-access barrier. Rather, it aims to connect regulatory, clinical, operational, and budgetary decisions that today are often made independently.

A level playing field does not mean protecting incumbent companies or excluding local manufacturers, regional firms, startups, or lower-cost suppliers. A locally produced technology may be better suited to the needs of a healthcare system. A lower-cost solution may be the most efficient. Likewise, a more expensive innovation may generate greater value if it improves outcomes and reduces downstream costs.

The playing field is leveled when a common regulatory floor exists and all participants are assessed according to transparent, objective, and comparable criteria. Evaluating value does not protect particular competitors. It protects the quality of decision-making.

Latin America must connect regulatory oversight, comparative assessment, procurement, adoption, and real-world evidence generation. Brazil and Mexico, given their scale and influence, are particularly well positioned to drive this transition. Colombia can contribute its institutional experience. Argentina and Chile can build on their recent reforms, while Peru and Ecuador can incorporate these principles as they continue consolidating their systems.

The next frontier for MedTech in Latin America is not merely regulatory. It is clinical, operational, economic, and social. Regulatory approval opens the door; healthcare value should guide which technologies we adopt, finance, and scale.