Brazil represents the largest market for medical devices in South America. However, manufacturers seeking to gain access to the Brazilian market face significant hurdles. The regulatory approval system for medical devices marketed or sold in Brazil is complex and dynamic, and requires product testing, INMETRO certification for certain devices, BGMP Inspections and registration at ANVISA (Agência Nacional de Vigilância Sanitária).
Before most electrical medical devices and some non-electrical medical devices can be registered at 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 either accredited by INMETRO or by members of the internationally recognised forums IAAC or ILAC are accepted. An INMETRO certificate will be issued for approved devices, which will also be authorized to display the INMETRO certification mark. INMETRO certification has a validity of 5 years. A re-certification 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 Program (MDSAP). For medical device registration at ANVISA, an audit report based on MDSAP would also be accepted.
TÜV SÜD can offer you a service to demonstrate compliance for your medical devices within the Brazilian market. We are accredited by INMETRO as a Certification Body (CB) for electrical medical devices and can provide INMETRO certification including initial and annual maintenance factory inspections. Our clients can choose to have factory inspections carried out parallel with other inspections (NRTL) or audits (ISO 13485/MDD). We also offer medical device testing in compliance with INMETRO requirements.
TÜV SÜD is also authorised to perform audits within the scope of the Medical Device Single Audit (MDSAP) program. Gain access to multiple markets by participating at the MDSAP that satisfies the needs of multiple regulatory authorities, including ANVISA in Brazil.
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