Regulation of Tissue Engineered Devices in some Latin American Countries: Development and External Influences

Abstract

Background: Emergence of new technologies and advances in tissue engineering strategies to treat diseases are shifting the conventional conception of medical devices. Tissue engineered products, manufactured as a combination of biomaterials, cells, and/or bioactive factors, are intended to temporarily restore an organ or tissue function, and induce the generation of newly site-appropriate functional tissue. Regulatory pathways for tissue engineered products require grouping policies controlling each of the components: materials, human cells, and active molecules. Purpose: To review current regulatory policies for medical devices (and within this, tissue engineered products), in a subset of Latin American countries, and to analyze the influence of international organizations and technological world power countries on policies of that subset. Methods: Top-down and horizontal diffusion models were employed to identify how regulatory policies have moved to Brazil, Colombia, Ecuador, Mexico, and Peru. Results: There are differences in technological appropriation to comprehensively define and classify medical devices. None of the countries have a definition of tissue engineered products. A top-down diffusion pattern was found to be associated with the current regulations. A horizontal diffusion is being applied as a regional effort to facilitate commercialization of medical products within Latin America. Conclusion: The concept of tissue engineered products is slowly arriving into the evaluated Latin American countries. Each country has the potential to take advantage of local institutions and regional and inter-regional coalitions to improve current guidelines and prepare the health system to the introduction of tissue engineered products.