QR Group Explica as Mudanças na RDC 954/2024 e Seu Impacto no Registro de Medicamentos
New ANVISA resolution updates criteria for simplified registration and brings greater clarity to the regulatory process With official publication in April and expected to come into force in October 2024, RDC No. 954/2024 brings an important update to the drug registration process with ANVISA. The new rule repeals RDC No. 199/2006 and redefines the criteria […]
QR Group analyzes the impacts of digitalization on toxicological risk assessment and registration processes in Brazil
ANVISA Implements New Tool for Toxicological Evaluation of Pesticides ANVISA announced the implementation of a new computerized tool for toxicological evaluation of pesticides, with the objective of modernizing and speeding up the technical analysis of these products. The solution integrates a set of functionalities that allow the agency to more efficiently process the data sent […]
ANVISA Receives Top Score for Good Regulatory Practices
QR Group analyzes the impact of agency performance for companies seeking registration of health products in Brazil ANVISA was rated 10 in the OECD Index of Good Regulatory Practices, according to a report released in April 2024. The index, prepared by the Organization for Economic Cooperation and Development, measures the quality of standard-making processes in […]
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 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, […]
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 […]
Dedicated Import of Medical Devices in Brazil
Integrated solutions for regulatory and logistics access Importing medical devices efficiently requires a dedicated process ranging from market research to customs clearance. QR Group performs a full dedicated import service, coordinating each step with technical and regulatory precision. Starting with the correct classification of the product, through the appointment of a local representative or qualified […]
