As set out in Ordinance No. 54/2016 issued by INMETRO, as of May 1, 2017, manufacturers will have to meet stricter INMETRO requirements. These requirements have significantly changed the previous regulatory system established by Ordinance No. 350/2010.
Among the main innovations, INMETRO focused on the risk management process of the manufacturers involved. In fact, they now have to submit more detailed documentation regarding the risk management and the quality management system subject to audit by accredited notified bodies and regulatory authorities.
INMETRO certificates issued before April 30, 2017 will remain valid for five years, after which time manufacturers will have to re-certify under Ordinance No. 54/2016.
Please note that INMETRO marking is a compulsory requirement for cadastro or registration with Anvisa for marketing purposes in Brazil and it is applicable to all classes of electro-Medical Devices.
For more information: http://www.puntofocal.gov.ar/notific_otros_miembros/bra605a1_t.pdf