Colombia modernizes device regulations simplifies translation requirements

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┬áEmergo Group, is an INVIMA (ColombiaΓÇÖs medical device regulator) communication that specifies that ΓÇ£registration materials pertaining to biocompatibility, […] [...]

Colombian Regulators Simplify Translation, Grouping Rules for Medical Device Registration

Colombian medical device regulator INVIMA has eased some translation and grouping criteria for market registrants. According to an┬áINVIMA communication, Colombia 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 […] [...]

New Drug Trial Seeks to Stop AlzheimerΓÇÖs Before It Starts

In a clinical trial that could lead to treatments that preventAlzheimerΓÇÖs, people who are genetically guaranteed to develop the disease ΓÇö but who do not yet have any symptoms ΓÇö will for the first time be given a drug intended to stop it, federal officials announced Tuesday. Experts say the study will be one of […] [...]