INMETRO and its Role in the Brazilian Medical Device Registration Process

Brazil’s medical device market expanded at double-digit rates through 2011-2013, and experts expect this growth to continue as 2014 transitions into 2015. Notably, imports account for approximately 80% of medical products in Brazil. Furthermore, as a member of the IMDRF and as a nation included in the Medical Device Single Audit Program (MDSAP), Brazil has actively taken strides to open its medical device market wider to the rest of the world.

In this context, INMETRO, the National Institute of Metrology, Standardization, and Industrial Quality of Brazil, plays an integral role in the medical device regulatory registration process. As an accreditation body and standardization organization, INMETRO operates at an important intersection between industry and ANVISA, the Brazilian medical device regulator. Specifically, electromedical device manufacturers who wish to market their devices in Brazil must obtain INMETRO certification as an additional and required step in their regulatory submission to ANVISA. However, this raises an important question: how does a manufacturer receive INMETRO certification?

To answer this, join LNE/G-MED North America in its free webinar, “INMETRO and its Role in the Brazilian Medical Device Registration Process.” During this session, we will cover:

• What INMETRO is and how it functions within the Brazilian government
• Where INMETRO fits into the Brazilian medical device registration process
• The process manufacturers follow to receive and maintain INMETRO certification