COFEPRIS: Self-Verification Guide for Warehouses Storing and Distributing Medicines and Other Health Supplies

COFEPRIS: Self-Verification Guide for Warehouses Storing and Distributing Medicines and Other Health Supplies

Mexico’s health regulatory authority, COFEPRIS, has published a Self-Verification Guide designed for companies operating warehouses that store and distribute medicines and other health-related supplies. This initiative aims to strengthen compliance with sanitary regulations, standardize procedures, and help businesses identify nonconformities—ultimately improving safety and traceability across the supply chain.

ANVISA Opens Public Consultation on New Regulatory Framework for Medical Devices in Brazil

ANVISA Opens Public Consultation on New Regulatory Framework for Medical Devices in Brazil

Brazil’s national health surveillance agency, ANVISA, has launched a targeted public consultation as part of its effort to revise and modernize the regulatory framework for medical devices. This initiative aims to align Brazilian regulations with international best practices, enhance patient safety, and foster innovation. Stakeholders across the health and regulatory sectors are invited to submit their contributions and insights.

Brazil Discusses Revisions to Allergen Labeling on Food Products

Brazil Discusses Revisions to Allergen Labeling on Food Products

Clear and accurate food labeling is essential for protecting consumers, especially those with food allergies. To improve transparency and safety, ANVISA recently held a virtual sectoral dialogue to discuss the revision of Brazil’s allergen labeling regulations. The initiative aims to update current standards, improve clarity for consumers, and align Brazilian practices with international regulatory trends.

Mexican Ministry of Health Advances with SaMD

Mexican Ministry of Health Advances with SaMD

The Mexican regulator, COFEPRIS, published the 5.0 edition of the Supplement for Medical Devices in the Mexican Pharmacopoeia, introducing regulatory requirements for Software as a Medical Device (SaMD).