In Vitro Diagnostic (IVD) reagents are regulated by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Food and Drug Surveillance Institute, or INVIMA) in Colombia. The regulatory framework for IVD reagents is based on Decree 3770/2004, amended by Decree 4124/2008 and Decree 581/2017. Other IVD devices (e.g., instruments or analyzers) fall under the conventional medical device regulatory framework of Decree 4725/2005. All IVD reagents require registration with INVIMA. An "automatic registration" pathway is available for low risk (Class I and Il) MDs, whereby registration is automatically granted upon submission of required documents. Class Ill IVDs require pre-market approval and may require additional approval from the Specialized Board for IVDs.

Read More