All medical devices sold in Brazil must register with the Agência Nacional de Vigilância Sanitária (ANVISA). ANVISA performs all registration and inspection functions within the agency.
Brazil’s Ordinance 54, Conformity Assessment Requirements for Equipment under Sanitary Surveillance took effect on 01-MAY-2017. Most of its requirements are the same as those of the previous Ordinance 350, but others , such as the scope of factory audits, have been substantially changed. In this document, we discuss in detail the requirements under Ordinance 54 to achieve and maintain INMETRO Certification under UL.
Scope of the mandatory INMETRO Certification?
The scope of INMETRO covers all products listed on both of these documents issued by ANVISA: “Resolução da Diretoria Colegiada RDC-27:2011” (RDC 27) and “INSTRUÇÃO NORMATIVA” (IN). The IN document is periodically updated and includes electro-medical devices and other devices that are not electrically powered, such as dental hand-pieces. This document also defines the implementation date for the compulsory certification for each type of product as well as the standards to be used.
For example, according to the latest IN (IN-4 published in 2015), products in the scope of the IEC 60601-2-26 will need compulsory certification only after December 2017.
PROCESS FOR NEW CERTIFICATIONS
A. Documentation Analysis
B. Audits at both manufacturing sites and local applicant in Brazil
C. Issue the certificate (valid for five years)