Medical Services

Brazil market access - UL's INMETRO mark

All medical device intended for sale in Brazil must be registered with the Agencia Nacional Vigilancia de Sanitaria (ANVISA). The registration process includes some basic requirements that must be fulfilled when applying for medical device registration in Brazil. The first stage is submission of technical documents to be sent directly to ANVISA. Secondly, electro-medical devices falling under the scope of IEC 60601-1 must be certified by an INMETRO accredited test agency and display the INMETRO marking.

UL do Brasil is an INMETRO accredited test agency for medical equipment and can provide the mandatory product certification and factory inspections required by the regulations.

In order to maintain this certification, manufacturers located outside of Brazil are subject to an annual surveillance assessment. The annual surveillance assessment focuses on certain aspects of ISO 9001 and routine production tests of the medical device. This evaluation must be performed by the certification agency irrespective of any ISO registration held by the manufacturer.

All medical devices shipped to Brazil are checked by Brazilian Customs against the ANVISA medical database for registration requirements and only then are allowed to enter Brazil.

The UL-BR Mark can help simplify your access to the Brazilian market. Once your product is certified, it will bear the INMETRO Mark as well as the UL-BR Mark. These processes can be merged with your existing UL testing and regulatory surveillance audit assessments.

Available Downloads

• Download an overview of UL's Latin America access services (PDF)