Understand the Requirements of IN 242/2023 and How to Ensure Regulatory Compliance
QR Group Explains ANVISA’s New Labeling Rules: How to Adapt Your Products Normative Instruction IN No. 242/2023, published by ANVISA, brought significant changes to the labeling of personal care products, cosmetics, perfumes, and disposables. Now, whenever there is a formula modification, the “NEW FORMULA” or “NEW COMPOSITION” statement must be included in the label. If […]
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 […]
QR Group Explains the Role of the Brazilian Registration Holder in Medical Device Regulation
How Foreign Manufacturers Can Market Medical Devices in Brazil For foreign medical device manufacturers to distribute their products in Brazil without having a licensed company in the country, it is necessary to appoint a Brazilian Registration Holder (BRH). This regulatory representative acts as the link between the company and the National Health Surveillance Agency (ANVISA), […]
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 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 […]
New Import Payment Flow: What Has Changed and How It Impacts the Medical Devices Sector
ANVISA Webinar Presents Changes in the Import Process On March 17, ANVISA held a webinar to clarify the new payment flow of the health product import process. The main novelty is the integration of the ANVISA Fee into the Centralized Foreign Trade Payment (PCCE) module of the Single Foreign Trade Portal (Siscomex). The measure aims […]
