An overview of the regulatory requirements for medical devices in Colombia
£40.00
Navigate the complex regulatory environment for medical devices in Colombia with this comprehensive overview
English
In Colombia, all medical devices must have a marketing authorisation, which is issued by the National Institute for Food and Drug Surveillance (INVIMA). In this article, María de la Luz Lara Méndez and Diego Alejandro Gutierrez Triana clarify the definition of a medical device in Colombia and the risk classification system. They describe the process for obtaining a health registration and the documents that must be submitted with an application. Fees and timeframes are also discussed. Finally, they explain the responsibilities of manufacturers and importers in Colombia’s national technovigilance programme.
Specification: 8 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the November 2023 issue of the Journal of Medical Device Regulation.
