The National Institute for Food and Drug Surveillance - Invima, informs manufacturers and importers of controlled technology medical devices and biomedical equipment issued Circular which clarifies and updates guidelines on the application of Decree 4725 of 2005.
The guidelines aim to reduce the concerns of users about the technical and legal documents that must be provided for procedures such as requests for new health registrations, renewals, and modifications.
A unified set of requirements is required to obtain health registrations and marketing permits. The certification process for manufacturers and importers of medical devices is rationalized. New parts, accessories, and spare parts are imported in accordance with standardized procedures and requirements.
Click this link to know more details on the Application related to Sanitary Registries of Medical Devices.