Manufacturers wishing to market their Medical Devices in Brazil must have their products registered with the competent national authority, Agência Nacional de Vigilância Sanitária (ANVISA). To become registered with ANVISA, most electrical Medical Devices require INMETRO certification.
TÜV SÜD do Brazil was recently granted accreditation by INMETRO and can act as an INMETRO certification body. Manufacturers that plan to place their Medical Devices on the Brazilian market can now commission us to assess and certify their electrical medical equipment for conformity with the requirements of INMETRO.
We also carry out the annual factory inspections that are required for achieving and maintaining certification. Our clients can opt to have factory inspections carried out parallel to their annual quality management audits.