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 […]
QR Group: How to Register Health Products with ANVISA and Ensure Compliance
Learn how QR Group can assist in the registration of health products with ANVISA and in the regulatory process to ensure entry into the Brazilian market. For a health product to be legally marketed in Brazil, it is essential that it goes through the registration process with ANVISA. This process involves a series of steps […]
Update of Brazilian Common Names: What Has Changed and How It Impacts the Pharmaceutical Sector
Understand ANVISA’s New Update and Its Impact on the Registration of Pharmaceutical Ingredients ANVISA published, in the Official Gazette of the Union, Normative Instruction 343/2025, which brings important changes to the list of Brazilian Common Denominations (DCBs). Eight new denominations were included, and one was changed, reinforcing the need for continuous updating of companies in […]
QR Group Analyzes the Debate on Regulation of Food Ingredients by Anvisa
Main Conclusions of Anvisa’s Sector Dialogue On 03/14, Anvisa held a virtual sector dialogue to discuss the regulation of food ingredient specifications, as defined by Project 3.8.1 of the 2024/2025 Regulatory Agenda. QR Group, a specialist in sanitary regulation, closely followed the discussions and highlights the main points addressed and their impacts on companies in […]
ANVISA Selects Priority Foreign Authorities to Strengthen Regulatory Confidence
Impact for Medical Device and Drug Manufacturers The National Health Surveillance Agency (ANVISA) approved, at a meeting of the Committee for Strategic Management, Risks and Institutional Innovation (CGE), the list of priority Foreign Regulatory Authorities. This decision aims to consolidate regulatory trust (“reliance”), accelerating registration and inspection processes of medicines and medical devices in Brazil. […]
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 […]
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 […]
Anvisa Prioritizes Registration of Tests for Arboviruses, Including Dengue and Chikungunya
Anvisa is implementing measures to speed up the registration of diagnostic tests for mosquito-borne diseases, aiming at better control of arboviruses in Brazil. The National Health Surveillance Agency (Anvisa) recently announced that it will prioritize the analysis of requests for registration of tests for the diagnosis of mosquito-borne diseases, such as dengue, chikungunya and oropouche […]
