Marketing in Brazil: do I need to get the INMETRO mark?

Medical device marketing authorization in Brazil involves both registration with ANVISA and, in some cases, a product certification process.

Particularly, in order to register with ANVISA, an INMETRO mark is required for the majority of electromedical devices and some non-active devices.

This mark is issued by a Certification Body accredited for INMETRO certification. The certification implies a Certification Body audit in the manufacturing company establishments and on the testing of the product subject to certification and registration. Annual inspections for the mark maintenance are also needed.