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 […]
Management Systems Optimization: How QR Group Ensures Quality and Compliance
The Importance of Implementing a Quality Management System In the healthcare industry, an efficient Quality Management System (QMS) is essential to ensure regulatory compliance, product safety, and operational efficiency. Companies that adopt and certify their QMS according to recognized standards, such as ISO 13485, have a competitive advantage and reduce the risk of non-compliance. QR […]
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 […]
ISO 13485 Certification for Medical Devices: Quality Assurance and Regulatory Compliance with QR Group
Understand how ISO 13485 certification, aligned with RDC 39/2013 and RDC 15/2014, is essential to ensure the quality and compliance of medical devices in Brazil. ISO 13485 certification is a fundamental requirement to ensure that medical devices meet the strict quality standards required by the market and Brazilian regulations, such as RDC 39/2013 and RDC […]
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 […]
How Avisalegis Can Make It Easier to Follow ANVISA Regulations
What is Avisalegis and How Does It Impact the Healthcare Industry? The National Health Surveillance Agency (ANVISA) recently launched Avisalegis, an innovative service that allows you to receive alerts about new regulatory publications. With this tool, medical device manufacturers, pharmaceutical companies, and other regulated industries can quickly keep up with any updates that impact their […]
Update of Brazilian Common Names: What Has Changed and How It Impacts the Pharmaceutical Sector
Understand ANVISA’s New Update and Its Impact on the Registration of Pharmaceutical Ingredients ANVISA published, in the Official Gazette of the Union, Normative Instruction 343/2025, which brings important changes to the list of Brazilian Common Denominations (DCBs). Eight new denominations were included, and one was changed, reinforcing the need for continuous updating of companies in […]
QR Group Explains RDC 947/2024: The End of Paper Protocol at ANVISA
Understand how the digitalization of ANVISA’s protocol impacts regulatory processes and how QR Group can help your company As of March 13, 2025, the National Health Surveillance Agency (ANVISA) will implement a 100% digital protocol for receiving documents, as established by RDC 947/2024. With this change, the submission of paper documents will no longer be […]
