Explore Brazilian regulatory standards (NR) for comprehensive insights on legislation
The Brazilian National Health Regulatory Agency (ANVISA) has initiated the rollout phase of the National Prescription Control System (SNCR). In doing so, the agency has published RD. No. 1.028/2026, which postpones the final deadline for the full operation of the system from Read More …
Importers of health-regulated products in Brazil must immediately adapt to a new customs regime. Effective April 27, 2026, the Brazilian National Health Regulatory Agency (ANVISA) has mandated the transition to the Single Import Declaration (Declaração Única de Importação – DUIMP). This new Read More …
Brazilian Health Regulatory Agency (ANVISA) has released Technical Note (NT) 51/2025, introducing crucial updates to the procedural guidelines for the registration and post-registration of biological products in Brazil. This new note complements and updates NT 134/2024, aiming to enhance the Read More …
The Brazilian Health Regulatory Agency (Anvisa) recently updated its pesticide toxicological assessment guidelines, ensuring stricter regulatory compliance and enhanced safety for public health and the environment. These revisions, became effective on December 23, 2024, aim to modernize the assessment of Read More …
The Brazilian Health Regulatory Agency (Anvisa) has introduced regulations aimed at bolstering public health defenses and operational efficiency in ports, airports, and customs facilities. The updated rules, outlined in Resolutions RDC 932/2024, RDC 938/2024, and RDC 939/2024, mark significant advancements Read More …
The Brazilian Health Regulatory Agency (Anvisa) has introduced a new list of subject codes for primary applications related to clinical trials of Advanced Therapy Products (ATPs), aligning with the requirements of Brazil’s updated Clinical Research Law (Law 14874/2024). This change Read More …
Brazilian Health Regulatory Agency (Anvisa) approved a new regulation that updates the rules for epidemiological surveillance in Brazil’s ports and airports. This new framework aims to reduce the risk of disease transmission through travelers and cargo, especially in light of Read More …
The Brazilian Health Regulatory Agency (Anvisa) has issued a critical warning regarding the use of unapproved stem cell products, especially those promising miracle cures and treatments. As the popularity of advanced therapies grows, Anvisa is stepping up its efforts to Read More …
The Brazilian Health Regulatory Agency (Anvisa) implemented RDC 848/2024, updating the essential safety and performance requirements for medical devices. This new regulation replaces RDC 546/2021 and introduces key changes, particularly the inclusion of in vitro diagnostic (IVD) devices. By aligning Read More …
The Brazilian Health Regulatory Agency (Anvisa) recently introduced RDC 894/2024, a new regulation aimed at enhancing post-market monitoring of cosmetic products in Brazil. This regulation, which comes into effect in 12 months, outlines stringent guidelines for ensuring consumer safety through Read More …