HEALTHCARE AND MEDICAL DEVICES E-SSENTIALS

Brazil: New INMETRO requirements suspended until 2017 

Surprising news from Brazil: Contrary to the original announcement INMETRO certificates can still be issued according to Ordinance 350/2010 until the end of 2016. With the new Ordinance 54/2016, a transition period until end of July 2016 had been announced. Not much time for manufacturers to take breath before adjusting to the new certification requirements that will demand greater scrutiny of risk management processes and procedures from 2017 on.

In the run-up the Brazilian regulatory authority had updated the INMETRO certification requirements for electrical medical devices to align with the 3rd edition of IEC 60601-1, amongst other topics focusing on risk management. In consequence, the new Ordinance 54/2016 will demand extra efforts from manufacturers regarding documentation, time for factory inspections, test planning and evaluation of the manufacturer´s legal representative.

Until the end of 2016 manufacturers can take the chance to ask for certification according to the old ordinance. If you’re interested, please contact us promptly in order to give us enough time to proceed your request.