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...
COFEPRIS
The Federal Commission of Protection against Health Risks (COFEPRIS), the Mexican state authority responsible for the medical devices regulation, issued guidance dedicated to the ventilators to be used in the context of the outbreak of the Coronavirus Disease 2019...
North America
All information submitted to the Mexican medical device regulating authority should be provided in the particular form set forth in the appropriate submissions guidance. The authority provides an exhaustive list of requirements the applicants must fulfill. Physical...
South America
COFEPRIS, Agency that regulates food, medical devices and drugs in Mexico, has issued 288,000 import and export permits for products in the last 5 years. COFEPRIS recently signed an agreement with the Confederation of Associations of Customs Agents of the Mexican...
South America
COFEPRIS, the decentralized division of the Department of Health in Mexico, is the governing body for medical devices and medicines. COFEPRIS has officially joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which bridges the most important regulatory...
