This article examines the need to conduct medtech clinical trials outside the U.S. and explores the growth of these trials in Latin America, particularly in Colombia and Paraguay. I will address critical success factors and provide recommendations to ensure cost-effective, ethical, and quality EFS and FIH medtech clinical trials in the region.
Read MoreColombia'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).
Read MoreLatin America is developing into that sizable, predictable part of the world market of medical devices. The region has developed into predictable, flourishing healthcare markets that would allow foreign manufacturers to have sustainable commercial operations. The Latin American market for medical devices and equipment is worth approximately an impressive US$30 billion.
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