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. […]
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, […]
