Mexico - Top Medical Device Alerts

List of International Recognitions by Regulatory Agencies COFEPRIS has released a list of international Recognitions by Regulatory Agencies to the knowledge of the users.
Health supply extensions are now digital and legally binding The legal validity of health record extensions can now be utilized two weeks earlier than the previously established date by the regulatory agency. For all medicines and medical devices granted health records by Cofepris, extensions are a necessary requirement. Before, the procedure had to be done at the regulatory body's headquarters every five years, with paper documentation being received and the review process taking weeks or months, causing five-year shortages. This redundant process was applied even to products with years of evidence in the market.
More than 49 thousand Cofepris public notices can now be modified online As part of the digitalization plan of the Federal Commission for Protection against Sanitary Riesgos (Cofepris), announced by the Secretary of Health, Jorge Alcocer Varela, on October 22, 2021, with just over 49,600 notices of operation of the establishment of supplies for health on paper can be modified over the internet.
Mexico - The first Spanish-speaking country to be a member of ICH Cofepris joined the ICH, making Mexico a strategic destination for clinical trials with processes equivalent to those of Europe, the United States, Canada, and Japan. Mexico is the fourth country in the Americas and the first Spanish-speaking nation to become an ICH member.
Cofepris and Conadic issue health warning for vapers and emerging tobacco products: they cause serious harm to health Conadic and Cofepris issued an alert based on scientific evidence, after a scientific-technical review by specialized personnel, that using vaporizers and smoke heaters has an alarming impact on lung health and reduces the capacity of people to respond to respiratory infections. However, it's worth noting that no vaporizer or smoke heater has Cofepris health authorization or recognition by the Ministry of Health as a reduced or alternative risk product.
How can RegDesk help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.