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 is expected to continue this rate as 2014 turns into 2015. About 80% of medical products in Brazil are imported. As a member of the IMDRF, and as a nation included in the Medical Device Single Audit Program (MDSAP), Brazil has made strides to open wider its medical device market to the rest of the world.

INMETRO, the National Institute of Metrology, Standardization, and Industrial Quality of Brazil, is an integral part of the medical device regulatory registration in Brazil. Its role as an accreditation body and standardization organization puts it at an important intersection between industry and ANVISA, the Brazilian medical device regulator. INMETRO certification is a requirement for electromedical device manufacturers who wish to market their devices in Brazil, and is an additional and required step in their regulatory submission to ANVISA. But how does a manufacturer receive INMETRO certification?

Join LNE/G-MED North America in its Free webinar, INMETRO and its Role in the Brazilian Medical Device Registration Process to find out. This webinar will cover:

• What is INMETRO and its role in the Brazilian government
• Where INMETRO fits into the Brazilian medical device registration process
• The process to receive, and maintain, INMETRO certification.