Written by ForeignExchange Translations on Wednesday, August 07, 2013
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!
The second bit of Colombian news also comes via Emergo. INVIMA in June published an updated list of products that qualify as medical devices. The deadline is December 31, 2013 for this expanded pool of products to obtain require market authorization so that they can continue to be legally sold in Colombia. Communication 500-2385-2013 is available here [PDF link; in Spanish].
It will be interesting to see what other changes will be forthcoming from INVIMA!
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