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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 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 […]

Classification and Grouping for Ultrasound Systems In Colombia

ultrasound classification

As mentioned in our 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 Article No. 5 of the decree 4725 of 2005.   In this publication, we will focus on explaining strategies to classify and group an ultrasound equipment […]

Applicable standards for Medical Devices

Medical devices are a broad group of products with different characteristics. Thus, many standards have been developed to establish general and particular specifications for them. In this text, we cover the most relevant international standards that can be found in the medical device industry that are useful for regulatory purposes.   ISO 13485 Medical devices […]