New law in Brazil changes enforcement of BGMP requirements for certain medical devices

New law in Brazil changes enforcement of BGMP requirements for certain medical devices-massdevice: For Class I and II lower-risk devices registered with ANVISA and included on the regulator's IN 2/2011 exception list, as well as for Class II in vitro diagnostic (IVD) devices, Brazilian Good Manufacturing Practice (BGMP) certification and fee requirements have been removed. Previously, devices included in IN 2/2011 – such as sterilization and disinfection equipment, blood component processing equipment, resonance imaging equipment, gels, creams and liquids that come into contact with the body, contact lenses, and software that edits medical images – required BGMP certification in order to obtain ANVISA approval. Now, IN 2/2011 devices must still go through the full “registro” application process, but without the BGMP certification requisite.