QR Group analyzes the main points of the proposal and advises companies on the regulatory impacts for registration and marketing in Brazil
ANVISA Opens Public Consultation to Update Rules for Medical Cannabis Products In July 2025, ANVISA opened a new Public Consultation to update RDC No. 327/2019, which currently regulates cannabis products for medical use in Brazil. The initiative aims to review technical and operational criteria to keep up with scientific evolution, ensure greater regulatory certainty, and […]
ANVISA Begins Review of RDC 81/2008: Impacts on Imported Products
QR Group analyzes the effects of the proposal to update the main rule that regulates the import of products subject to health surveillance in Brazil In 2024, ANVISA began the process of revising RDC No. 81/2008, a rule that for more than 15 years has established the requirements for importing products subject to health surveillance, […]
Regulation of Medications for Rare Diseases Advances in Brazil
QR Group analyzes the regulatory impacts of ANVISA’s new guidelines and the challenges for the pharmaceutical industry In recent years, the regulation of medicines for rare diseases in Brazil has undergone significant advances. ANVISA has been working to make registration processes more flexible and faster, especially for innovative drugs aimed at treating conditions with a […]
ANVISA Approves Gene Therapy for Duchenne Muscular Dystrophy
QR Group analyzes the impact of the arrival of Elevidys in Brazil and the advancement of gene therapy regulation In July 2024, the National Health Surveillance Agency (ANVISA) approved Elevidys (delandistrogene moxeparvovec-rokl), the first gene therapy indicated to treat Duchenne muscular dystrophy (DMD) in Brazil. The drug is manufactured by Sarepta Therapeutics and had already […]
ANVISA Updates Rules for Importing Medical Device Components
QR Group explains regulatory impacts and guides companies on how to maintain compliance safely ANVISA has published a new technical statement on the regulatory framework for medical device components, bringing important clarifications for manufacturers, importers and distributors. The update reinforces the need to evaluate, on a case-by-case basis, the destination and risk of the components, […]
QR Group Explains ANVISA Updates on Smoking Product Registration
Changes require attention from companies to maintain regulatory compliance and avoid penalties In July 2024, the National Health Surveillance Agency (ANVISA) published an update on the criteria for registration and renewal of tobacco-derived smoking products, such as cigarettes, cigars, and cigarillos. The measure reinforces the need for attention on the part of companies in the […]
QR Group offers advice on regulatory matters for product registration with ANVISA
Understand how QR Group’s regulatory affairs advice speeds up ANVISA approval for national and international manufacturers With a focus on regulatory affairs, QR Group offers complete advice for product registration with ANVISA, aiming to ensure compliance and agility in accessing the Brazilian market. In this content, we explain how this personalized advice strengthens the entry […]
How Generative Artificial Intelligence is Transforming the Brazilian Health Sector
Discover how the adoption of generative AI is driving productivity and reinvention for healthcare companies in Brazil. Generative Artificial Intelligence (AI) is becoming a crucial tool for the healthcare sector in Brazil, bringing productivity and efficiency gains to companies. According to the 28th edition of the Global CEO Survey, 58% of healthcare CEOs in Brazil […]
The Trends of the Health Sector in Brazil and the Impact of Technological Innovation
How Technological Innovation and Generative AI Are Transforming the Healthcare Market in Brazil The 28th Global CEO Survey revealed that business leaders are increasingly focused on reinventing their business models to generate value, ensure sustainability and drive innovation. In the healthcare sector in Brazil, this trend translates into the accelerated adoption of generative artificial intelligence, […]
Back-Office Structure for Medical Device Distribution in Brazil: How to Improve Efficiency and Compliance
How Does a Back-Office Structure Optimize Medical Device Distribution? The distribution of medical devices in Brazil involves operational and regulatory challenges that require efficient management. A well-organized support structure simplifies administrative tasks, improves operational efficiency, and ensures compliance with ANVISA regulations, providing sustainable growth for companies in the sector. Order Processing: Reducing Errors and Ensuring […]
