Posts tagged first-in-man
Three Steps for a Medical Device Startup to Run a First-In-Human Clinical Trial in Colombia and Gather Quality Data at a Fraction of the Cost

Colombia's Ministry of Health (MoH) has one of the fastest regulatory approval times in Latin America: 30 days. The country also boasts a top-performing universal healthcare system that covers about 95% of its 50-million population and competitive hospital fees that are about 30-50% less than in the US or other Western European countries. The EC and INVIMA will evaluate the study protocol, the investigator's brochure, the patient informed consent form (ICF), the case report form (CRF), all information about the investigational product (e.g., biocompatibility tests, reports of unexpected adverse events), the study insurance policy, and all advertising material planned to recruit patients. You must also apply for an import permit at VUCE (Ventanilla Única de Comercio Exterior) —an office within Colombia's Ministry of Commerce, Industry, and Tourism (MinCIT).

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