The protection of public health and the regulation of medical products are the responsibility of governments. Medical devices are an important component of health care and encompass a wide variety of products. But in unregulated markets, common in a large number of Latin American countries, anyone can launch a medical device on the market. The absence of rules and requirements means that manufacturers or importers do not know what to comply with. This webinar analyses Chile's experience in developing a regulatory framework for medical devices and how the Criteria Network supported this South American country in its alignment with international standards, implementing a regulation that adopts a gradual approach.