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Colombia: Medical Device Classification

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Hello everyone, and welcome back to another week of MedTech Compliance Chronicles! This week, we continue exploring Colombia’s regulatory landscape by diving into medical device classification. Understanding how a device is classified is a crucial first step to entering any regulated market. Classification determines the level of regulatory scrutiny and dictates the path to market, and while many countries share similar frameworks, each has its unique nuances.


In Colombia, medical device classification follows a globally familiar risk-based model but diverges in some key ways. Unlike the United States, which has three device classes and groups IVDs under the same regulations as general medical devices, Colombia separates IVDs into their own classification framework. This adds a layer of complexity for manufacturers entering the market but ensures greater clarity for these distinct product types.


This post aims to provide an overview of how INVIMA, Colombia’s regulatory body, classifies general medical devices and IVDs. By the end, you will gain a clearer understanding of the classification rules and how they apply to your device.



General Medical Devices


Colombia classifies general medical devices into four classes: I, IIa, IIb, and III. Classification is determined based on the intended use, invasiveness, duration of use, and whether the device is active. INVIMA’s classification system is outlined in Directive 4725, which includes 18 rules to guide manufacturers. While all rules should be reviewed for each device that is attempting classification, some general themes to the rules are outlined below to assist with basic understanding. 


Key Rules and Considerations:

  • Invasiveness: Devices that penetrate the body are subject to stricter rules.

    • Devices in contact with the heart or central nervous system are automatically Class III, given the critical risk to life.

  • Duration of Use:

    • Transient Use (<60 minutes): Class I (e.g., syringes, ECG electrodes).

    • Short-Term Use (60 minutes–30 days): Class IIa (e.g., wound dressings, catheters).

    • Prolonged Use (>30 days): Class IIb or III (e.g., implants, pacemakers).

  • Active Devices: Devices powered by electricity or other external energy sources are classified based on their potential risks.

    • Devices emitting hazardous energy (e.g., therapeutic lasers) are Class IIb or higher.

    • Devices performing diagnostic functions (e.g., blood glucose monitors) are typically Class IIa.


When applying the rules, manufacturers must note that a device falling under multiple rules will always default to the highest applicable classification. Additionally, INVIMA does not permit reclassification based on post-market data or evolving standards, which can present challenges for manufacturers.


In Vitro Diagnostic Devices


We now come to a category of devices we have never specifically addressed before, in vitro diagnostic devices. IVDs in the US are classified in the same manner and have all of the same applicable regulations as all medical devices. In Colombia, INVIMA has established a separate regulation and classification scheme for IVDs. 


First, we will give a little context as to why some regulatory bodies decide to make such distinctions in the first place. General medical devices are usually intended to be used directly on patients or for therapeutic and diagnostic purposes in direct interaction with the human body (e.g., surgical instruments, implants, monitoring equipment). IVDs on the other hand are usually intended to be used outside the human body to analyze samples like blood, urine, or tissue to diagnose diseases, monitor health conditions, or guide treatment decisions. The interaction is indirect because the device analyzes a biological sample, rather than being used directly on the patient. These key differences result in differing approaches to analyzing the risk of the device and, as medical device classification is all about risk, some regulatory authorities believe it better to keep them separate. While medical device risk is generally assessed in terms of patient safety, IVD risk is generally assessed in analytical performance and diagnostic reliability. Since an IVD is not likely to directly harm a patient, it does not make much sense to categorize them in such a way. However, inaccurate diagnosis could lead to misinformed treatment (or lack of treatment), which could subsequently lead to harm to the patient. Additionally, some IVDs meant to detect contagious diseases or diseases with a high morbidity rate can have greater implications on the public health of a nation at large, unlike most other medical devices.


Now, with a solid understanding of the distinction between IVDs and other medical devices, let’s get into how IVDs are classified in Colombia. Thankfully, IVD classifications are a little less complex. A general overview of the classification of IVDs is outlined below:


  • Class I: General laboratory reagents (e.g., culture media, buffer solutions).

  • Class II: Most diagnostic tests (e.g., blood glucose test kits, pregnancy tests).

  • Class III: High-risk tests, such as those for contagious diseases with high morbidity (e.g., HIV diagnostic kits) or for transplant (blood, tissue or organ) compatibility and donor screening.


Conclusion


Understanding medical device classification is the foundation of any successful market entry strategy in Colombia. This post has introduced the key rules and considerations for classifying general medical devices and IVDs under INVIMA regulations. While Colombia’s approach shares similarities with global frameworks, its distinctions—such as separating IVDs and prohibiting reclassification—require careful attention from manufacturers.


The next step for manufacturers is to thoroughly review INVIMA’s classification rules and ensure their devices meet the appropriate regulatory requirements. By doing so, you will lay the groundwork for a smooth approval process and pave the way for successful market entry in Colombia.


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