INMETRO Certification for Medical Devices

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.

The Regulation “Resolução da Diretoria Colegiada RDC no. 549:2021” by ANVISA provides policy and establishes the INMETRO mandatory certification scheme for electromedical equipment as a pre-requirement to register the product with ANVISA for entry into the local market.

The regulation also indicates the mechanism of “Instrução Normativa” that prescribes the standards and implementation date which each equipment must comply with.

In this document, we cover in detail the requirements per Ordinance no. 384:2020 to achieve and maintain INMETRO Certification under UL Solutions.