Medical Device Clinical Trial Regulatory Timeline and Costs in Latin America
Latin America presents an advantageous location for conducting clinical trials involving medical devices. Our infographic provides a comprehensive overview of the regulatory timelines and associated costs pertinent to clinical studies within this region. Compared to other regions, the regulatory review processes in Latin America are notably expedited.
The sequential steps required to initiate a medical device clinical trial in most Latin American countries are as follows:
The review process for an institutional review board (IRB) or ethics committee (EC) in Latin America typically spans between 15 and 45 days.
A national regulatory agency, usually affiliated with a ministry of health (MoH), can take between 90 and 180 days to approve the study.
The import permit approval process generally requires between 7 and 15 days.
It is noteworthy that national regulatory agency/MoH approval is not necessary in Chile and Panama.
The financial implications of conducting a medical device clinical trial in Latin America are illustrated below:
Hospital costs range from $5,000 to $60,000 per patient, resulting in a significant cost savings of 30-50% compared to U.S. or Western Europe hospital fees. These costs encompass start-up expenses, overhead, record archiving, screening, procedure, and trial closure.
Contract research organization (CRO) fees typically range from $80,000 to $350,000, depending on the duration of the study and other factors such as adverse event reports, monitoring visits, and additional non-budgeted activities.
Third-party fees, including insurance policies, translations, IRB/EC/Ministry of Health approvals, importations, and travel expenses, can accumulate to approximately $50,000.
