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 […]
RDC 954/2024: Updates to the Simplified Drug Registration Procedure
Key Changes and Impacts for Drug Manufacturers The recent update of RDC 954/2024 brought significant changes to the simplified procedure for registering medicines in Brazil. In an exclusive event held by ANVISA on March 13, experts discussed the main guidelines and their impacts on the pharmaceutical sector. QR Group has closely followed the news to […]
Anvisa Postpones Deadline for Migration of Cosmetics Registration System to Solicita
Understand the impact of the change and how to ensure regulatory compliance with QR Group The National Health Surveillance Agency (Anvisa) announced a change in the transition period from the Cosmetics Registration Automation System (SGAS) to the Solicita/Datavisa platform. The Resolution of the Collegiate Board (RDC) 966/2025, published on February 28, defined that the rules […]
QR Group Explains Anvisa’s Approval of 124 Drugs for Rare Diseases
Advanced Regulation Boosts Treatments for Rare Diseases Anvisa has played a key role in the approval of drugs aimed at rare diseases, achieving a total of 124 approvals in the last eight years. This advance reflects the agency’s commitment to optimizing regulatory processes, ensuring more therapeutic options for patients facing diseases that are often chronic, […]
