Before most electrical medical devices and some non electrical medical devices can be registered with ANVISA, they must successfully achieve INMETRO certification through an INMETRO accredited certification body. A factory inspection prior to INMETRO certification is also required. In order to maintain the INMETRO certification, annual factory inspections have to be carried out.
For INMETRO certification, only test reports from organisations that are accredited by members of the internationally recognised forums IAAC, EA or ILAC are accepted. An INMETRO certificate will be issued for approved devices, which will also be authorised to display the INMETRO certification mark. INMETRO certification has a validity of 5 years. A re-registration has to be performed once the INMETRO certification has expired.
All medical devices in classes III and IV (comparable to classes IIb and III in accordance with 93/42/EEC) are subjected to Brazilian GMP (BGMP) inspections carried out by ANVISA in two-year intervals. Alternatively, manufacturers can participate in the Medical Device Single Audit Programme (MDSAP). For medical device registration at ANVISA, an audit report based on MDSAP would also be accepted.
TÜV SÜD’s global network of medical device technical experts represents an effective single source for manufacturers worldwide seeking access to the Brazil medical device market. TÜV SÜD do Brazil is accredited by INMETRO and can act as an INMETRO certification body. TÜV SÜD can assess and certify electrical medical equipment for conformity according to INMETRO requirements and carry out the annual factory inspections that are required for achieving and maintaining INMETRO certification. The annual factory inspections can be conducted in parallel with other annual quality management audits.