INMETRO is a certification body, testing laboratory designated body, and also a regulatory body for product safety and energy efficiency. The INMETRO certification is largely operated as a third-party certification system and a self-declaration of conformity system, and depending on the product, the certification system will be applied differently.
ANATEL has divided the items subject to compulsory certification into three different categories, and each item must satisfy the technical requirements. For ANATEL certification, after issuance of a certificate from a designated certification authority through product testing (ISO9001 is required for classes), it has to be finally registered with ANATEL.
Brazil's medical device classification system is similar to Europe's fundamental regulation 93/42/EEC. ANVISA requires medical device manufacturers to comply with Brazilian Good Manufacturing Practices (GMP), and INMETRO certification is further required for electrically powered devices.