New regulations were recently enacted by Brazil's National Health Surveillance Agency (ANVISA). Under the new regulations, manufacturers of Class I or II medical devices with electrical components that require INMETRO certification will now no longer require obligatory compliance with Brazilian Good Manufacturing Practices (BGMP) inspections.
ANVISA's Normative Instruction (IN) 2/2011, which replaces IN 7/2010, provides a specific list of Class I and II electronic devices requiring BGMP certification. Many Class I and II electronic medical devices are not included in this list and now require only INMETRO certification as part of their ANVISA registration in Brazil. Please note, all Class III and IV medical devices, whether they contain electrical components subject to INMETRO or not, still require BGMP certification.
The new list of Class I and II electronic medical devices requiring BGMP certification includes:
Unlike under IN 7/2010, where all Class I and II devices subject to INMETRO certification were automatically required to also comply with BGMP, manufacturers of Class I and II electrical medical devices not on the list above no longer have to obtain BGMP certification, nor pay the biennial fee or go through re-certification every two years in order to register their devices in Brazil, although INMETRO certification may still be required. As such, manufacturers whose Class I and II medical devices do not appear in the IN 2/2011 list now have the benefit of lower costs to sell in Brazil.