Before medical device manufacturers can legally sell their products in Brazil, they must be in compliance with Brazilian medical device regulations set forth by the Agência Nacional de Vigilância S

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For manufacturers of electronic medical devices seeking to sell their products in Brazil, electrical safety testing and certification from The National Institute of Metrology, Standardization and Industrial Quality (INMETRO) may be required in order to obtain National Health Surveillance Agency (ANVISA) registration.

Companies that want to sell medical devices or IVD products in Brazil must comply with Brazilian Good Manufacturing Practice (GMP) quality system requirements. These requirements are specified in Brazilian resolution RDC 16/2013.

Medical device manufacturers must audit their quality systems on a regular basis to ensure compliance with the appropriate regulations and standards.

In today's fast changing and increasingly complex regulatory environment, many companies are choosing to outsource some medical device regulatory affairs and quality assurance tasks as a way to ensure quality system and regulatory compliance.