Wearable Medical Devices: Regulatory Affairs in Argentina

Due to the high relevance of wearable devices on healthcare, many companies and research groups are focusing on the development of novel wearable systems by combining diverse technologies such as flexible electronics, nanomaterials, artificial intelligence, and machine learning. Some of these devices can be regarded as medical devices (MDs). In consequence, they must satisfy rigorous standards as every biomedical product to guarantee their safety and quality to the users and the environment. The purpose of this work is to define a criterion for a wearable system to be regarded as a medical device or not and review the regulatory framework for wearable medical products in order to surpass the barriers between an academic prototype and a medical device released to the market.