Most of our attention is focused on medical device regulations in Europe and Asia. But Latin American countries are also hard at work to update their regulations. Two bits of news out of Colombia today.
First, according to Emergo Group, is an INVIMA (Colombia’s medical device regulator) communication that specifies that “registration materials pertaining to biocompatibility, risk analysis, sterilization, and clinical studies and test reports may now be submitted to reviewers in their language of origin; summaries of study descriptions, methods and conclusions must be provided in Spanish”. Regulatory managers with responsibility for Latin America will rejoice at the fact that, for once, fewer translations are required!
