Mexico
This article details the process of modifying existing registration entries for medical devices permitted for marketing and use in Mexico. Table of Contents Mexico’s medical device regulatory authority, COFEPRIS, has released guidance on changes to the sanitary...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a safety communication dedicated to the reprocessing of flexible bronchoscopes. The document provides...
South America
Lets talk about current medical device regulations in Mexico. Medical devices in Mexico are regulated by the Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). The agency classifies...
