INMETRO certification of health products is required by ANVISA to demonstrate compliance with regulatory requirements for safety and performance. Needles, Syringes and Infusion Sets, in their majority, have compulsory certification in Brazil, and will only be able to receive authorization for sales and manufacturing from ANVISA after INMETRO certification. The Certificate of Conformity is valid for five years, subject to the requirements necessary to maintain its validity, established in INMETRO's Ordinances 458/2021, 461/2021, 84/2021, 385/2021 and 200/2021 (RGCP).