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.