Medtech Clinical Trial Regulatory Timeline and Cost in Colombia
Find out why Colombia is a prime destination for medical device clinical trials. Our infographic provides a detailed look at the regulatory timelines and costs of conducting clinical studies in this country. Colombia's regulatory review times are relatively fast compared to other major countries in Latin America. The following are the sequential steps to get your medical device clinical trial started in Colombia:
The review process for an IRB (institutional review board), known as an ethics committee (EC) in Colombia, can take 15 to 30 days.
Colombia's regulatory agency (INVIMA, a dependency of the Ministry of Health) can take between 90 and 120 days.
The import permit approval can take between 7 to 15 days.
Clinical trial costs in Colombia are significantly lower than in the United States.
Hospital costs range from $5000 to $20,000 per patient, representing a 30-50% savings compared to U.S. hospital fees. These costs cover start-up, overhead, record archiving, screening, procedure, and trial close-out.
CRO fees are between $75,000 and $200,000, depending on the duration of the study and other factors (e.g., adverse event reports, monitoring visits, additional non-budgeted activities).
Third-party fees such as insurance polity, translations, IRB/EC fees, import permits, and travel expenses can amount to about $30,000.
