The end of paper at Anvisa! Electronic Protocol is the future of Health Surveillance

RDC 954/2024 -Comprehending the Highlights and Impacts on Drug Registration

The Brazilian Health Surveillance Agency (ANVISA) will fully adopt the electronic document protocol from March 13, 2025, as established by RDC 947/2024. This change will eliminate the need for paper documents, promoting greater agility in document analysis, modernizing processes and reducing operating costs, especially those related to digitization and physical storage.

Integration of the Health Surveillance Fee into the Single Foreign Trade Portal: Timetable and Impacts for Brazilian Trade

Integration of the Health Surveillance Fee into the Single Foreign Trade Portal: Timetable and Impacts for Brazilian Trade

Anvisa (the National Health Surveillance Agency), in partnership with the Foreign Trade Secretariat (Secex) and the Federal Revenue Service, has announced the integration of the payment of the Health Surveillance Fee into the Single Foreign Trade Portal (Siscomex). This change is part of a move to centralize and digitize foreign trade processes, offering more agility, transparency and simplicity for importers and exporters dealing with products subject to health surveillance.

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).

Exploring the Diversity of Medical Devices for Health Promotion in Brazil

Overview: Brazil stands out as the main market for medical devices in Latin America, with an established, albeit complex, regulatory system. Medical products in the country are regulated by the National Health Surveillance Agency (ANVISA). Against this backdrop, we explore the main types of medical devices and their specific applications within the Brazilian context. Introduction: […]