INMETRO Safety certification for medical devices with electrical and other components has changed in Brazil.

Previously, INMETRO certifiers in Brazil have allowed foreign manufacturers to obtain INMETRO certification directly as part of their registration process. However, when the new INMETRO regulation, Portaria 350/2010 (Document in Portuguese), was implemented in September 2011 it included text that stated foreign manufacturers could no longer hold INMETRO certifications in their own names.

Instead, INMETRO certification must be held by a Brazilian entity, which should be the same entity that is appointed as the foreign manufacturer’s Brazil Registration Holder. That said, ANVISA had verbally indicated in a meeting post-release of Portaria 350/2010 that they did not actually intend that foreign manufacturers could not hold their own INMETRO certifications. Therefore, many INMETRO certifiers continued to allow non-Brazilian companies to contract services directly.

However, Emergo Group’s Brasilia office has learned that new leadership at INMETRO has begun requiring certifications to be held and maintained only by companies based in Brazil.

For foreign manufacturers required to obtain INMETRO certification to register their devices in Brazil, this means their Brazilian Registration Holders (BRH) will have to hold INMETRO certification on their behalf. Furthermore, INMETRO certifications already in force will need to be revised to reflect BRHs and not foreign manufacturers as certificate holders.

Foreign manufactures in the process of appointing BRH partners for devices that must undergo INMETRO testing and certification should therefore verify that any potential in-country representation partner can properly obtain INMETRO certification as well as manage ANVISA registration.