INMETRO Certification for Medical Devices Sold in Brazil

Access the Brazilian market by meeting the requirements for your medical device

Establish a presence in the Brazilian medical device market by fulfilling all necessary prerequisites. Brazil holds the largest market share for medical devices in South America. However, navigating the Brazilian market poses significant challenges for manufacturers. The regulatory approval process for medical devices sold in Brazil is intricate and ever-changing, involving product testing, INMETRO certification for specific devices, BGMP inspections, and registration with ANVISA (Agência Nacional de Vigilância Sanitária).

Prior to registering with ANVISA, most electrical medical devices and certain non-electrical medical devices must successfully obtain a certificate from an accredited INMETRO certification body. Additionally, a factory inspection is mandatory before the certification is granted.  It is important to highlight that a local legal representative needs to be established to represent the devices in the local market.  An assessment of the legal representative is also mandatory.

To obtain the certification, only test reports from organizations accredited laboratories members of internationally recognized forums such as IAAC, EA, or ILAC are accepted. Approved devices receive the certificate and are authorized to display the certification mark. The certification is valid for five years, requiring re-certification upon expiration.

Medical devices classified as III and IV (equivalent to classes IIb and III under 93/42/EEC) are subject to Brazilian GMP (BGMP) inspections conducted by ANVISA every two years. Alternatively, manufacturers can participate in the Medical Device Single Audit Program (MDSAP). ANVISA accepts an audit report based on MDSAP for medical device registration. The lead time to complete a MDSAP assessment with a third-party auditor is usually shorter than to schedule a BGMP assessment by ANVISA.

Annual factory inspections and assessment on the local legal representative are required to maintain the certification.

Our services at a glance

At TÜV SÜD, we offer comprehensive services to ensure compliance with Brazilian market regulations for your medical devices. As an INMETRO-accredited Certification Body (CB) for electrical medical devices, we provide the certification, including initial certification and the annual maintenance assessments. Our clients have the flexibility to schedule factory inspections simultaneously with other inspections (NRTL) or audits (ISO 13485/MDR), reducing costs and complexity. Additionally, we offer medical device testing in adherence to both local and international requirements.

TÜV SÜD is also authorized to conduct audits within the scope of the Medical Device Single Audit Program (MDSAP). By participating in MDSAP, you can access multiple markets while meeting the regulatory requirements of various authorities, including ANVISA in Brazil.

• Accepted Test Reports - TÜV SÜD test reports are recognized and can support the INMETRO certification process performed by accredited organizations.
• INMETRO Certification - As an INMETRO-accredited certification body, TÜV SÜD can certify your medical device based on INMETRO standards and conduct the necessary annual factory inspection for the certification. 
• Medical Device Single Audit Program (MDSAP) - TÜV SÜD is authorized to conduct audits as part of the MDSAP pilot program. By participating in MDSAP, you can expand your market reach and meet the regulatory requirements of multiple authorities, including ANVISA in Brazil.