The National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos or INVIMA) is regulatory authority created in 1992 under the Ministry of Health. INVIMA is in charge of inspecting and supervising the marketing and manufacturing of health products, identify and evaluate the violation of health standards or procedures, as well as implementing best practices and providing medical approval for the import and export of products.
The entity within INVIMA that deals with medical device matters is the Directorate for Medical Devices and other Technologies (Dirrection de Dispositivos Medicos y otras Tecnologias), subordinated directly to the General Directorate. The directorate monitors and controls medical devices, tracks pre and post marketing programs and, among others, suggests technical standards for the manufacturing, marketing, surveillance and quality assurance of devices.
Some of the most important regulations for medical devices in Colombia are:
A full list of INVIMA regulations can be found here.
- Website: https://www.invima.gov.co/