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  1. Julio G. Martinez-Clark
    Colombia's Ministry of Health (MoH) has one of the fastest regulatory approval times in Latin America: 30 days. Colombia's clinical trial regulatory agency —INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)— is a dependency of Colombia's MoH. The site's Institutional Review Board (IRB)/ethics committee and INVIMA must evaluate and approve all research on human beings in Colombia. Both the IRB 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), an 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).
    Julio G. Martinez-Clark
    3 Steps for a Medical Device Startup to Run a Foreign Clinical Trial in Colombia and Cost-Effectively Gather Data for FDA/CE Mark Approval
    www.linkedin.com Colombia's Ministry of Health (MoH) has one of the fastest regulatory approval times in Latin America: 30 days. Colombia's clinical trial...
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