Brazil Medical Device Regulations

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 is complex and dynamic. It requires product testing, INMETRO certification for certain devices, BGMP Inspections and Brazil medical device registration at ANVISA (Agência Nacional de Vigilância Sanitária). Most electrical medical devices and some non-electrical medical devices must successfully achieve INMETRO certification before they can be registered at ANVISA. Only an INMETRO accredited certification body such as TÜV SÜD can ensure this. INMETRO certification of medical devices also requires a factory inspection for initial certification and annual factory inspections to maintain the certification.

Only test reports from organizations accredited by INMETRO or by members of the internationally recognized forums such as IAAC or ILAC are accepted for INMETRO certification of medical devices. Once certified, approved devices can display the INMETRO certification mark. INMETRO certification has indefinite validity, under the condition that the necessary certification maintenance is carried out.

All medical devices under class III and IV (comparable to class IIb and III according to the EU Regulation) 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 Brazil ANVISA medical device regulations, an audit report based on MDSAP would also be accepted.

TÜV SÜD is one of the world’s largest Notified Bodies for medical devices. Regulatory authorities recognize us for our extensive experience with all types of medical devices. Our Regulatory Affairs, Foreign Affairs and Clinical Centre of Excellence adds to our expertise.

We are an INMETRO accredited Certification Body (CB) for electrical medical devices. We 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 (e.g. ISO 13485/MDR). Our engineers/auditors/experts have deep knowledge of local regulations and speak your language.

We are also authorized to perform audits within the scope of the Medical Device Single Audit (MDSAP) program. You can access multiple markets by participating in the MDSAP, which satisfies the needs of multiple regulatory authorities, including Brazil ANVISA medical device regulations.

Medical device approvals routinely require the implementation of a quality management system. We conduct quality management system certifications, audits and factory inspections consistent with most international regulations and standards. This allows clients with coordinated inspections and audits, while optimising time and cost for registration.

Our service includes: 

• Accepted test reports – We perform testing's a and provide test reports that can support INMETRO certification performed by INMETRO accredited organizations. 
• INMETRO certification – We are an INMETRO accredited certification body. We can test and certify your medical device based on INMETRO standards. We can also perform the annual factory inspection required for INMETRO certification. 
• Medical Device Single Audit Program (MDSAP) – We are authorized to perform audits within the scope of the MDSAP pilot program. This serves as a comprehensive solution to gain access to multiple markets.