Description: As part of emerging countries efforts to protect the population against sanitary risks related with medical devices, Health Authorities often trend to emulate and adapt references regulations from Stringent Regulatory Authorities. However, the emergence of software intended to be used for medical purposes exceeds the scope of local regulations considering current medical devices controls were designed to control physical medical devices. The rise of new medical technology with the possibility of direct and immediate interaction with the user, challenges not only the traditional evolution of the local regulation, but the speed of response and the Health Authority evaluator´s profile. Some emerging countries Health Authorities had adopted the figure of a Third Party evaluator for Drugs and Medical devices, which can be the short-term answer for the regulation of SaMD (like FDA´s pilot program). Cooperation and alignment within Health Authorities, Medical Industry and platforms that will offer these kind of products is crucial to understand and dimension the need of appropriate strategies to regulate digital products that expose the population to immediate diagnosis.
Learning Objectives:
Have a general view of the current emerging markets situation
Understand the limits of the current regulation
Know alternatives to speed the process of local regulation
