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 INVIMA 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 in Spanish.

 

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