ANVISA certification
and registration process

The National Sanitary Surveillance Agency (Agência Nacional de Vigilância Sanitária -ANVISA) is the body responsible for regulating medical products in Brazil. It adopts the Brazilian System for Conformity Assessment  (Sistema Brasileiro de Avaliação da Conformidade – SBAC) established by INMETRO as an instrument to guarantee the safety and quality of medical devices of medium and high risk to health.

The SBAC is structured in a decentralized way and seeks in the certification the continuous improvement of quality, being for the stakeholders a reference that a product, process or service, meets minimum standards of quality.

The mechanism within the SBAC adopted is voluntary certification through a Conformity Assessment Regulation (Regulamento de Avaliação da Conformidade - RAC) issued by INMETRO, which establishes the mechanisms used for the conformity assessment. Currently, INMETRO 350/2010 is in transition for the adoption of the INMETRO Ordinance 54/2016.

Although the process is voluntary before INMETRO, the compulsory nature is given by ANVISA, which requires among other things the certification of medical devices to register and allow the marketing in the national territory.

The 601 series of norms is adopted for certification as well as other applicable national or international norms. The list of applicable norms is periodically defined by ANVISA based on the existence of accredited or trained laboratories, and currently the list of applicable norms is defined by Normative Instruction 04 of ANVISA of 2015, or simply IN04 / 2015.

The body authorized to issue product certification, called Product Certification Bodies (Organismos de Certificação de Produto - OCP), must be accredited by the CGCRE, based on the principles and policies adopted within the SBAC.

The choice of the test laboratory follows the rule defined in the Conformity Assessment Regulations, but prioritizes the execution of tests in laboratories Accredited by the CGCRE.

E3Tech's commitment is to reduce deadlines and costs for its customers.

Through this constant search, we have formed partnerships throughout the more than 15 years of activity in this segment which allow us to affirm that this is possible. Due to the great volume and constant demand that E3Tech has with Product Certification Bodies and Laboratories, we have achieved different terms, prices and commercial conditions for our customers.

E3Tech has partnerships with the best laboratories and certifiers in the market and manages to offer the best price and the shortest time available in the market. In addition, it has a highly qualified technical staff, who solves all kinds of problems to make the certification task something simple.


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Phone: +55 (19) 2222-3328
E-mail: sales@e3tech.com.br
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