QR Group Explains How to Sell Class III and IV Medical Devices in Brazil: Certification and Compliance Requirements
Learn how to obtain the GMP certification required to register Class III and IV medical devices with ANVISA with the help of QR Group. To market Class III, Class IV or IVD medical devices in Brazil, it is essential that foreign manufacturers obtain Good Manufacturing Practices (GMP) certification from ANVISA. This process is crucial to […]
Anvisa and USP sign new Memorandum of Understanding for health regulations.
Fortalecimento da Cooperação Regulatória entre Brasil e EUA A Agência Nacional de Vigilância Sanitária (Anvisa) e a Farmacopeia Americana (United States Pharmacopeia – USP) assinaram um novo Memorando de Entendimento, consolidando uma parceria iniciada em 2016. O acordo, com vigência de cinco anos, visa ampliar a colaboração técnica e científica, fortalecendo a regulação sanitária no […]
Anvisa Implements Tool to Speed Up Toxicological Assessment of Pesticides
New rule optimizes analysis of petitions and reinforces security in pesticide regulation As of January 2, 2025, Anvisa’s Collegiate Board Resolution (RDC) 950/2024 comes into force, establishing complementary requirements to optimize the toxicological evaluation of pesticides formulated from equivalent technical products. The measure aims to make processes more efficient, maintaining scientific rigor and ensuring safety […]
Review of RDC 81/2008 and its Impacts on Imported Products
Understand How the Regulation Update Affects the Import of Health Products and How QR Group Assists Companies in the Process On May 15, the National Health Surveillance Agency (ANVISA) approved the Regulatory Impact Analysis Report (RAIR) regarding the revision of the Technical Regulation of goods and products imported for health surveillance purposes. This step represents […]
