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 electro medical device manufacturers who wish to market their devices in Brazil, and is an additional and required step in their regulatory submission to ANVISA.
What is INMETRO and what is its role in medical device certification?
How does an electromedical device manufacturer receive INMETRO certification?