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 […]
RDC 954/2024 Updates Simplified Medication Registration
QR Group analyzes the impacts of ANVISA’s new rule and guides companies on how to adapt to changes in the regularization process ANVISA published RDC No. 954/2024, which updates the criteria and procedures for the simplified registration of medicines. The new rule repeals the old RDC No. 199/2006 and comes into force as of October […]
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 […]
Medical Device Registration: Agile Compliance with ANVISA
Understand the Medical Device Registration Process at ANVISA Ensuring access to the Brazilian market requires a detailed regulatory process, especially in the registration of medical devices with ANVISA. QR Group’s registration service was developed to facilitate this journey, ensuring compliance, agility, and strategy for companies that want to operate safely in the health sector. Complying […]
QR Group Explains the Classification of Odor Neutralizers: Cosmetics or Sanitizers? Enviar feedback Resultados de tradução disponíveis
Understand how ANVISA’s regulation impacts the classification of odor neutralizers and QR Group’s role in adapting to standards. The classification of odor neutralizers has raised doubts in the market, especially about whether they should be treated as cosmetics or sanitizers. RDC Resolution No. 752, of 2022, and RDC No. 59, of 2010, provide the guidelines […]
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, […]
Medical Device and In Vitro Diagnostic Registration: The Complete Guide for Foreign Manufacturers in Brazil
Understand how ANVISA regulations affect the registration of medical devices and in vitro diagnostics and how QR Group can help with compliance. Brazil, the largest medical device market in Latin America, offers great growth opportunities for international manufacturers. However, the regulatory process for medical devices and in vitro diagnostic products requires detailed attention to ANVISA […]
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 Explains ANVISA’s Good Manufacturing Practices Inspection for Medical Devices
Understand how GMP inspection impacts the registration of medical devices and how QR Group facilitates the compliance process. ANVISA requires that a Good Manufacturing Practices (GMP) Inspection be carried out at the facilities of manufacturers of risk class III and IV medical devices, whether national or international, as part of the process for product registration. […]
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 […]
