Classification and Grouping for Dialysis machines in Colombia
As mentioned in our Device Classification and Grouping Guide, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules are fully explained in Decree 4725 of 2005. In this article we will focus on explaining strategies to classify and group a Dialysis machine and the common accessories related […]
Classification and Grouping for Urology Devices in Colombia
When registering Medical Devices in Colombia, the classification and grouping strategy is a key activity for optimizing the number of registrations (based on 18 rules). You can find some examples of the classification and grouping criteria in our previous articles for: Orthopedic Implants Ultrasound Systems Medical Imaging In vitro Diagnostics Surgical instruments In […]
Classification and Grouping for Stents in Colombia
A stent is a small mesh tube that is placed inside a hollow structure in the body to keep it open. As mentioned in our Classification and Grouping Guide, there are a series of rules to consider when classifying and grouping medical devices in Colombia. In this article we will focus on explaining strategies […]
Classification and Grouping for Balloon Catheters in Colombia
Balloon Catheters also known as dilatation catheters, stand as precise instruments in the array of medical devices. Employed to alleviate obstructions and stenosis across various bodily systems, they are a great exemplification of controlled intervention. In this article, we will discuss their structure, diverse applications, and existing types of Balloon Catheters. Additionally, we will […]
Classification and Grouping of gloves in Colombia
In our Device Classification and Grouping Guide, we have explained how to classify and group medical devices in Colombia according to the 18 rules detailed in the article 7 of the Decree 4725 of 2005 . In addition, we have also explained how to make use of those rules to classify and group specific medical […]
Semantic Standard and Coding of Medical Devices for Colombia
Recently, INVIMA has released a resolution regarding the semantic report (a tool for identifying products based on UDI codes -more details below), marking a significant development in the regulation of medical devices and in vitro diagnostic reagents (IVDs) in Colombia. In this article, we will delve into this new process and explore its key aspects […]
Classification and Grouping of Intraoral Scanners in Colombia
As explained in the Colombia Classification and Grouping Guide, there is a comprehensive set of regulations for the categorization and grouping of medical devices (fully explained in the 1725 of 2005 decree, specifically in Article No. 5). Using this regulatory framework as the legal basis, we will study in this article the classification and […]
Classification and Grouping of Bone Substitutes in Colombia
Within our Classification and Grouping Guide, we explain a comprehensive set of regulations for the categorization and grouping of medical devices. These regulations are fully explained in the 1725 of 2005 decree, specifically in Article No. 5. In this publication, we will delve on the strategies employed in the classification and grouping of bone […]
Classification and Grouping for Medical Imaging Systems in Colombia
As mentioned in our Classification and Grouping Guide, there are a series of rules to consider when classifying and grouping medical devices. These rules are fully explained in Article No. 5 of the decree 4725 of 2005. In this publication, we will focus on explaining strategies to classify and group medical imaging systems, following simple […]
Classification And Grouping For Surgical Instruments In Colombia
As mentioned in our Classification and Grouping Ultimate Guide, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules are fully explained in the decree 4725 of 2005 by INVIMA. In this article, we will focus on explaining strategies to classify and group surgical instruments following simple general […]
