Myoelectric Prostheses: Classification and Grouping in Colombia.
Myoelectric prostheses are technologically advanced medical devices designed to support individuals with limb loss by restoring functional movement. These systems interpret electromyographic (EMG) signals from residual muscles to control motorized components, offering enhanced precision and adaptability compared to conventional mechanical prostheses. In Colombia, the INVIMA regulates the registration and commercialization of medical devices, including prosthetic technologies. […]
Oximeters: Classification and Grouping in Colombia
Oximeters are commonly used in healthcare settings to monitor blood oxygen saturation (SpO₂) and pulse rate. These devices play a role in respiratory assessment, perioperative care, and chronic disease management. In Colombia, the classification and registration of oximeters are governed by the regulatory framework established in Decree 4725 de 2005, which outlines the sanitary registration process for medical devices. […]
Intragastric Balloons: Classification and Grouping in Colombia.
Intragastric balloons are non-surgical medical devices used in weight control therapies. Designed for temporary placement in the stomach, they help reduce food intake and promote satiety, supporting weight loss in individuals with overweight or obesity. This article outlines the structural features, clinical applications, and regulatory classification of intragastric balloons within the Colombian healthcare system. Structure and […]
Colombia’s Medical Device Market 2024: Trade Rankings and Regulatory Outlook
Introduction Following the 2023 annual report, we now present the 2024 edition of our Medical Device Market Overview for Colombia. This analysis examines Colombia’s performance in medical device importation, while also highlighting developments in the country’s healthcare infrastructure and market dynamics. With updated trade data and industry insights, the report outlines why Colombia is becoming […]
Software as a Medical Device (SaMD) in Colombia: Classification and Regulatory Guidelines
Colombia’s medical device regulations include software in their scope and define classification rules, documentation requirements, and registration processes managed by INVIMA. This framework is primarily contained in Decree 4725 de 2005. Rapid progress in digital health (AI diagnostics, mobile monitoring, dose calculators) means stakeholders need clear criteria to determine when software is regulated as a device, how to classify risk, […]
Humidifiers and Heated Wire Breathing Systems: Classification and Grouping in Colombia
This article concludes our series on respiratory therapy-related medical devices, which has examined components such as anesthesia circuits, oxygen masks, and breathing systems. In this final segment, we focus on the regulatory pathway for registering humidifiers and heated wire breathing systems (HWBS) in Colombia, a growing market of interest for global medical device manufacturers. […]
Mechanical Ventilators: Classification and Grouping in Colombia
As part of our series on respiratory therapy devices, this article focuses on a cornerstone of airway management: the mechanical ventilator. Often referred to as respirators, these devices are used when patients cannot maintain adequate breathing independently. In addition to exploring ventilator functionality and classification, we examine the regulatory landscape for introducing mechanical ventilators into […]
Anesthesia Machines: classification and grouping in Colombia
Continuing our series on respiratory and anesthesia-related medical technologies, this article examines the anesthesia machine. Previous entries have addressed devices such as anesthesia masks and circuits, which are integral to maintaining airway control and gas exchange during procedures. In this installment, we shift our attention to the anesthesia machine itself. This guide offers a […]
Breathing Systems: Classification and Grouping in Colombia
This article continues our series on classification of medical devices related to respiratory therapy in Colombia, where we have covered topics like anesthesia circuits and oxygen masks. In this edition, we turn our attention to the regulatory framework for registering breathing systems with INVIMA, What is a Breathing System? Breathing systems are specialized […]
Anesthesia Circuits: Classification and Grouping in Colombia
This article continues our series on anesthesia-related medical devices. Having previously covered anesthesia masks, endotracheal tubes and laryngeal masks, we now turn our attention to the regulatory process for registering anesthesia circuits in Colombia What are Anesthesia Circuits? Anesthesia circuits, also known as anesthesia breathing systems, are essential components in modern surgical and […]