Challenges for companies and inspectors in interpreting the requirements of legislation and international standards of Health Surveillance
One of the biggest challenges for companies that manufacture or import/distribute health products is understanding and/or interpreting regulatory requirements, whether they are resolutions/legislation or international standards of the Health Surveillance Agency. The applicability of certain requirements in certain segments must be carefully assessed by both companies and authorities, which makes the inspection process by health […]
Registering Medical Products in Brazil – What do you need to know?
Registering medical products in Brazil goes through ANVISA – the National Health Surveillance Agency – which is the agency responsible for approving the marketing of any product related to human health in Brazil. The agency divides products into categories, such as health products, cosmetics, cleaning products, medicines, food, cannabis products and tobacco. The first step […]
Anvisa Launches Consultation Panel for Active Ingredients of Medications with Drug Registration Process
New Anvisa Tool Brings Transparency to the Brazilian Drug Registration Process Anvisa has just made available an online dashboard that allows users to consult the active ingredients of drugs with registration requests still under analysis. The tool is an innovation that promotes transparency in the regulatory process, offering a detailed view of the different categories […]
Spending on Medication Represents 33.7% of Brazilian Families Health Expenditure in 2021, According to IBGE
Understand how the Growth in Spending on Medication Impacts the Economy and QR Group’s Role in Access to Health Products In 2021, Brazilians spent R$168.3 billion on purchasing medications, representing 33.7% of household spending on healthcare, according to data from IBGE. This increase reflects both the impact of the pandemic and the aging of the […]
Anvisa Publishes English Version of IN 289/2024: Regulatory Convergence and Efficiency
How IN 289/2024 Facilitates the Registration and Post-Registration Process for Medicines and Biological Products in Brazil Anvisa has just released the English version of Normative Instruction (IN) 289/2024, reinforcing the agency’s commitment to international regulatory convergence. The new standard establishes procedures to streamline the registration and post-registration analysis of medicines, biological products, vaccines and Cadifas. […]
QR Group Reports: Anvisa Extends Participation Deadline in Pilot Project for Innovative Medical Devices
Understand how the extension of the deadline for the pilot project for regulatory evaluation of innovative medical devices impacts the healthcare sector and how QR Group can help. Anvisa has extended the deadline for submitting Innovative Medical Devices projects in the pilot project for regulatory evaluation, now with a deadline until January 19, 2024. This […]
In Vitro Diagnostic Devices: Update on ANVISA’s Petitioning System under RDC 830/2023
QR Group provides guidance to international manufacturers on new regulatory requirements for in vitro diagnostic devices and how to adapt to RDC 830/2023 ANVISA will carry out an important update to its electronic petitioning system between May 29 and June 3 to comply with RDC 830/2023, which establishes new rules for the risk classification, registration, […]
