Medical equipment registration is mandatory for products belonging to the Classes III and IV. As determined by RDC nº 185/2001. The other equipment and materials are certified according to the requirements of Anvisa and INMETRO. …

The registration of products at Anvisa is established so that the products can be marketed in Brazil. To register the Oximeter with Anvisa, the manufacturer must first hold the AFE - Authorization for the operation of the company (Anvisa) and all the requirements …