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 […]
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 […]
ANVISA Selects Priority Foreign Authorities to Strengthen Regulatory Confidence
Impact for Medical Device and Drug Manufacturers The National Health Surveillance Agency (ANVISA) approved, at a meeting of the Committee for Strategic Management, Risks and Institutional Innovation (CGE), the list of priority Foreign Regulatory Authorities. This decision aims to consolidate regulatory trust (“reliance”), accelerating registration and inspection processes of medicines and medical devices in Brazil. […]
QR Group Explains the Impact of the Mais Médicos Program in Brazil
Understand how the Mais Médicos program is strengthening healthcare in Brazil, with 95% of vacancies filled by professionals trained in the country and the growing participation of quota holders The Mais Médicos program, which has reached its 38th cycle, continues to expand access to healthcare in Brazil, filling 95% of new vacancies with professionals trained […]
