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.

所有欲在巴西销售的医疗器械必须在巴西卫生部（ANVISA）进行注册。注册程序包括了一些在巴西申请医疗器械注册必须完成的基本要求。第一步是直接向ANVISA递交技术文件。第二步，凡在IEC 60601-1范畴内的电子医疗器械必须由INMETRO认可的测试机构进行认证并标上INMETRO标志。

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.

UL巴西分公司是经INMETRO认可的认证机构，可对医疗器械进行认证并提供法规要求的强制性产品认证服务和工厂验厂服务。
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.

为了维持认证的证书，在巴西境外的生产厂家均需进行年度的跟踪评审。年度的跟踪评审重点关注于ISO 9001的审核和医疗器械的常规生产测试。评估必须由认证机构执行，而无论生产厂家是否持有ISO注册证书。
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.

所有运至巴西的医疗器械将由巴西海关根据ANVISA的注册要求医疗数据库进行检查，只有经过检查才允许进入巴西。

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.

Medical Services

UL-BR标志可帮助你简化进入巴西市场的手续。一旦产品通过认证，将标上INMETRO和UL-BR标志。这些认证过程可与现有的UL测试和法规所要求的跟踪审核评估过程合二为一。转自：医疗器械网