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 […]
ANVISA Receives Top Score for Good Regulatory Practices
QR Group analyzes the impact of agency performance for companies seeking registration of health products in Brazil ANVISA was rated 10 in the OECD Index of Good Regulatory Practices, according to a report released in April 2024. The index, prepared by the Organization for Economic Cooperation and Development, measures the quality of standard-making processes in […]
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 […]
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 […]
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 […]
Anvisa Resumes Monitoring of Medical Device Prices: What Does This Mean for the Sector?
Transparency and Regulation: QR Group Explains the Resumption of Data Publication Anvisa has resumed the publication of medical device price monitoring data on its Business Intelligence (BI) dashboards. This activity, previously suspended due to the Agency’s internal restructuring, once again offers crucial information for the health sector. With this resumption, companies in the segment have […]
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 […]
QR Group Explains the Changes in RDC 954/2024 and Its Impact on Drug Registration
Understand How the Changes in RDC 954/2024 Impact Drug Registration and How QR Group Assists International Manufacturers With the entry into force of RDC 954/2024, the drug registration process undergoes significant changes. The rule revises and simplifies the regulatory procedure, promoting greater speed in the registration, post-registration and renewal processes. QR Group, a specialist in […]
RDC 954: Simplified Registration of Medications and Its Impacts
ANVISA Event Details Changes in RDC 954/2024 On March 13, ANVISA held an exclusive event on RDC 954/2024, which brings important updates to the simplified registration of medicines. The high demand for face-to-face participation led to the opening of online transmission, allowing a greater number of professionals to follow the changes in real time. QR […]
