ANVISA Cancels In Vitro Medical Devices That Failed to Meet Reclassification Deadline
QR Group warns of the impact of non-compliance with the requirements of RDC 36/2015 and guides companies on how to keep their records in compliance In July 2025, ANVISA announced the cancellation of registrations of medical devices for in vitro diagnosis (IVD) that did not meet the deadline for sanitary reframing, established by RDC No. […]
ANVISA Defines Priority Foreign Regulatory Authorities
QR Group analyzes how the strategy strengthens regulatory trust and facilitates the registration of health products in Brazil In 2024, ANVISA released the list of priority foreign regulatory authorities to strengthen the process of regulatory trust in Brazil. The measure is part of the agency’s regulatory agenda and aims to streamline analysis and decisions through […]
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 […]
CMED Opens Directed Consultation on Pricing of Advanced Therapies
QR Group analyzes regulatory impacts and what companies need to consider in the commercialization of gene, cell and tissue therapies The Drug Market Regulation Chamber (CMED) has started a targeted consultation on the pricing of advanced therapies — such as gene, cell, and tissue therapies. The measure aims to receive contributions from the regulated sector, […]
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 […]
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 […]
