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ANSWERED ON THIS PAGE: How are medical devices classified in Brazil? How does classification affect registration requirements for our device? What is considered a device family by ANVISA?

ANSWERED ON THIS PAGE: Are we required to appoint an in-country representation to sell in Brazil? What should we consider when choosing a Brazil Registration Holder (BRH)? What are the responsibilities of a Brazil Registration Holder?

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 Brazil Good Manufacturing Practice (B-GMP) quality system requirements. These requirements are specified in Brazilian Resolutions RDC 16/2013 and RDC 39/2013.

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.