Brazil Market Access
Accessing the Brazilian market for medical devices
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, certification and registration plus ANVISA (Agência Nacional de Vigilância Sanitária) inspections. INMETRO certification is required for most active and some non active medical devices. In order to achieve and maintain INMETRO certification, periodic factory inspections are required.
All medical devices imported or distributed in Brazil must be registered with ANVISA. However, only companies based in Brazil can apply directly for ANVISA registration. Manufacturers without a subsidiary in Brazil which intend to place medical devices on the market there must obtain representation by a Brazilian Registration Holder (BRH) recognised by ANVISA. The responsibility for submitting the application for approval together with the technical documentation with ANVISA rests with the BRH. Resolution RDC 185/01 sets forth the requirements regarding the content of the technical documentation to be submitted.
Only test reports from organisations that are accredited by members of internationally recognised forums such as IAF or ILAC are accepted for INMETRO certification. Approved devices are issued an INMETRO certificate and are authorised to display the INMETRO certification mark.
Before most electrical medical devices and some non active medical devices can be registered with ANVISA, they must be certified by a certification body accredited by INMETRO. A factory inspection prior to certification is also required. In order to maintain the INMETRO certification, annual factory inspections have to be carried out.
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 exclusively by ANVISA in two-year intervals. In June 2011, ANVISA published Normative Instruction (IN) 2/2011 on medical devices in classes I and II (comparable to classes I and IIa in accordance with 93/42/EEC), which are also covered by the biennial BGMP inspections. Any medical devices in classes I and II not included in this Normative Instruction are excluded from inspections.
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.
- Accepted test reports - TÜV SÜD test reports can be used in support of INMETRO certification performed by INMETRO-accredited organisations.
- Factory inspections - TÜV SÜD can assist with required factory inspections in order to obtain and maintain INMETRO Certification. In many cases, required factory inspections can be conducted in coordination with audits required for other quality management systems.
All medical devices imported or distributed in Brazil must be registered with ANVISA. However, only companies based in Brazil can apply directly for ANVISA registration. Manufacturers without a subsidiary in Brazil which intend to place medical devices on the market there must obtain representation by a Brazilian Registration Holder (BRH) recognised by ANVISA. The responsibility for submitting the application for approval together with the technical documentation with ANVISA rests with the BRH. Resolution RDC 185/01 sets forth the requirements regarding the content of the technical documentation to be submitted.
Only test reports from organisations that are accredited by members of internationally recognised forums such as IAF or ILAC are accepted for INMETRO certification. Approved devices are issued an INMETRO certificate and are authorised to display the INMETRO certification mark.
Before most electrical medical devices and some non active medical devices can be registered with ANVISA, they must be certified by a certification body accredited by INMETRO. A factory inspection prior to certification is also required. In order to maintain the INMETRO certification, annual factory inspections have to be carried out.
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 exclusively by ANVISA in two-year intervals. In June 2011, ANVISA published Normative Instruction (IN) 2/2011 on medical devices in classes I and II (comparable to classes I and IIa in accordance with 93/42/EEC), which are also covered by the biennial BGMP inspections. Any medical devices in classes I and II not included in this Normative Instruction are excluded from inspections.
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.
- Accepted test reports - TÜV SÜD test reports can be used in support of INMETRO certification performed by INMETRO-accredited organisations.
- Factory inspections - TÜV SÜD can assist with required factory inspections in order to obtain and maintain INMETRO Certification. In many cases, required factory inspections can be conducted in coordination with audits required for other quality management systems.
Your benefits at a glance
- Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Affairs Department, TÜV SÜD Product Service is recognised by regulatory authorities for its extensive experience with all types of medical devices.
- Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing TÜV SÜD clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees worldwide.
- Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
- Regional and local proficiency - Our regional medical health experts speak your local language and understand regional and local regulations and knowledge needs.