ANVISA Updates Cosmetics Regulations in Brazil
QR Group explains the main changes and guides companies on how to maintain compliance safely and quickly In April 2024, ANVISA published the new Normative Instruction (IN) No. 280/2024, which changes relevant aspects of the regulation of cosmetics and personal care products in Brazil. The measure updates the technical requirements for regularization, with a focus […]
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 and MAPA Discuss Regulation of Cannabis-Based Products for Veterinary Use
QR Group analyzes the regulatory impacts and prospects for companies working with medical cannabis in Brazil The advancement of the debate on the regulation of cannabis-based products for veterinary use in Brazil gained new developments with the recent meeting between representatives of ANVISA and the Ministry of Agriculture and Livestock (MAPA). The meeting, held in […]
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 […]
ANVISA and WHO: QR Group Explains Impacts on Medical Product Regulation
How ANVISA’s role at the WHO influences the regulation of medical devices in Brazil The recent appointment of ANVISA as Brazil’s official representative on the Executive Board of the World Health Organization (WHO) has important implications for the regulation of medical devices in the country. With a strong technical performance, the Brazilian agency reinforces its […]
QR Group Explains Logistics Operations: What Medical Device Companies Need to Know
Logistics Operations: integrating compliance and efficiency in the healthcare chain Operating medical device logistics in Brazil requires absolute control of regulatory processes, inventory management, and transportation under specific conditions. QR Group’s logistics operations were developed to combine regulatory expertise with operational efficiency, offering a comprehensive service that includes planning, execution and real-time monitoring of the […]
Bonded Warehouse: Safe Storage for Healthcare Products
Bonded Warehouse: Compliance and Efficiency for Medical Devices Storing imported medical devices requires technical structure, strict management, and regulatory compliance. QR Group’s bonded warehouse service offers complete support from receipt to release for commercialization, ensuring that products are under strict control, either at the appropriate temperature or in safe areas, as required by ANVISA and […]
QR Group Explains Distribution Operations Management: What Medical Device Distributors Need to Know
Distribution Operations Management: control and efficiency in the logistics chain Managing the inventory and distribution of medical devices in Brazil requires complete visibility into inventory levels, accurate tracking, and efficient execution. QR Group offers a specialized service in the management of distribution operations, integrating technology, compliance and logistics control to ensure that your products arrive […]
