Anvisa Gets a Grade 10 Performance in Good Regulatory Practices: Understand the Impact and How QR Group Can Help in the Process
CGU audit recognizes Anvisa’s excellence in good regulatory practices; learn how this reflects on healthcare product regulation and how QR Group supports manufacturers. The Office of the Comptroller General of the Union (CGU) recently evaluated Anvisa, along with other regulatory agencies, regarding the adoption of good regulatory practices. Anvisa stood out for meeting all the […]
QR Group Explains Changes in ANVISA Cosmetics Regulation
Understand how the migration to the Solicita platform impacts the regularization of cosmetics in Brazil and how QR Group can assist in this process. ANVISA announced the extension of the deadline for the migration of the Cosmetics Registration Automation System (SGAS) to the Solicita/Datavisa platform. With the effectiveness of RDCs 949/2024 and 951/2024, the new […]
Evolution of Regulation for Rare Disease Drugs in Brazil
Understand how ANVISA’s regulation has accelerated the approval of drugs for rare diseases and the impact on international manufacturers. Health regulation in Brazil has undergone significant advances in recent years. One of the most impacted sectors is medicines for rare diseases, which registered a significant growth in the number of approvals by ANVISA. In the […]
Regularization of Cannabis-Based Products for Veterinary Use
Understand how the new measure impacts the regulation of veterinary products and how QR Group can help companies in the process. On October 30, ANVISA’s Collegiate Board approved a measure that allows the regularization of cannabis-based products for veterinary use by the Ministry of Agriculture and Livestock (MAPA). The decision amends Ordinance SVS/MS 344/1998, allowing […]
Elevidys® Approval by ANVISA: The Impact of Gene Therapy for Duchenne Muscular Dystrophy
Understand the Approval of Elevidys and How QR Group Assists® in the Registration Process of Innovative Products in Brazil The approval of Elevidys® (delandistrogen moxeparvoveque) by ANVISA for the treatment of Duchenne Muscular Dystrophy (DMD) represents a milestone in the area of advanced therapies in Brazil. QR Group, with its expertise in medical device and […]
QR Group Explains Anvisa’s New Rules for Importing Medical Device Components
Understand how the updates to RDCs 860/2024 and 939/2024 impact the import and storage of medical device components and accessories in Brazil Anvisa has updated the processes and flows related to the import and storage of medical device components. With the recent publication of Collegiate Board Resolutions (RDCs) 860/2024 and 939/2024, importers need to understand […]
Update on Smoking Product Registration and Renewal: What Companies Need to Know
Understand how the update of ANVISA’s guidelines affects the registration and renewal of smoking products and how QR Group can help in the process. ANVISA recently updated its guidelines on the registration and renewal of smoking products derived from tobacco. This change is included in the Collegiate Board Resolution (RDC) 896/2024, which reformulates the requirements […]
ANVISA’s Participation in WHO: Impacts on the Regulation of Medical Products
Understand the Importance of ANVISA’s Role in the Global Product Regulation ANVISA is participating in the 13th plenary meeting of the Member States Mechanism on Substandard and Falsified Medical Products (MSMSF) of the World Health Organization (WHO), reinforcing its essential role in product regulation at the international level. The event will take place between November […]
QR Group Explains Data Sharing Agreement Between Anvisa and FDA
Understand how the new agreement between Anvisa and the FDA can speed up drug approval in Brazil and how QR Group can help your company comply. The National Health Surveillance Agency (Anvisa) and the Food and Drug Administration (FDA), the regulatory body in the United States, have signed an important confidentiality agreement that will facilitate […]
Simplifying the process: regularizing products at ANVISA
Understand the essential steps for regularizing products with ANVISA and how QR Group can help your company ensure compliance quickly and safely. If you work in the industry of products that require regularization with the health surveillance agency, you know that regularizing products with ANVISA is a crucial step, not only for marketing, but also […]
