Hello everyone and welcome to a very special post in MedTech Compliance Chronicles! This blog series has so far brought us from knowing nothing about US medical device regulations all the way through placing a medical device on the market in the United States. While there are still many activities to be done in maintaining a marketed medical device there are still many more markets to place that medical device on as well. The world is becoming more and more global, as modern technology makes it easier for smaller and smaller businesses to expand their footprint outside of their home nations. Medical devices, in particular, benefit from many free trade agreements and even attempts at simplification of regulatory burdens across different countries.
Today, we’ll introduce you to the medical device regulations in Colombia. You may be wondering, why look at Colombia next? South America has emerged as an attractive option for medical device investment, and the United States’ Trade Promotion Agreement with Colombia—and several other South American countries—enables the free trade of many medical devices, with nearly all devices anticipated to trade freely by 2028. This agreement, coupled with the relative affordability of entering these markets compared to others, has spurred significant interest from smaller U.S. manufacturers. Let’s dive into Colombian medical device regulations and learn how to navigate this market!
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What is INVIMA?
INVIMA stands for Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or National Institute for Food and Drug Surveillance in English. In short, INVIMA is the Colombian FDA, their regulatory body responsible for the regulation of medical devices. The regulatory oversight of both bodies are very similar, being primarily focused on food, drug and health products. FDA has the additional scope of regulating tobacco and radiation emitting products, while INVIMA places regulations on dietary supplements, which are usually not regulated in the United States.
As far as their regulation of medical devices goes, there are some key differences with the United States. First, the US FDA was the very first regulatory body of its kind, ever, being almost 120 years old, while INVIMA is relatively new, with operations officially starting in 1995. This comes with advantages and disadvantages. On one hand, INVIMA is much more aligned with international regulation, as many regulatory bodies around the world already existed at the time of its creation. On the other hand, certain processes are not quite as refined and fine-tuned as in the United States. In general, many of their overall requirements are quite similar. You must register your organization and devices, apply for market approval, follow good manufacturing practices and perform basic post-market surveillance activities in both markets.
For medical devices specifically, a notable distinction is in the way INVIMA classifies devices. Colombia, like many countries, classifies devices solely by their initial risk level—based on factors such as the device’s intended use, anatomical contact points, and inherent hazards. Unlike the FDA, INVIMA does not allow reclassification as new standards emerge. For instance, in the United States, a high-risk (Class III) device may later be reclassified as a Class II device if industry standards make its safe production more straightforward. Colombia, on the other hand, maintains the initial classification regardless of advances in standardization. This is a point of ongoing debate in global regulatory circles: while the U.S. model reduces regulatory burden and enables agencies to focus on emerging high-risk devices, many countries argue that retaining higher scrutiny for all high-risk devices, even mature ones, better ensures public safety.
Conclusion
This post has offered a brief introduction to INVIMA and the regulatory landscape for medical devices in Colombia. As we continue this series, we’ll explore Colombian medical device regulations in greater detail and eventually expand to cover other South American markets. Understanding each country’s regulatory framework is vital as we work to bring innovative medical devices to patients around the world.
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