Considering the existence of a significant number of medical devices sold in Chile, the existence of a surveillance system that provides information to those involved in the use of medical devices is essential. Technovigilance aims to improve health protection, both for patients and users, reducing the likelihood of adverse events occurring in clinical practice.
Technical Standard No. 204, On Patient Safety and Quality of Care in the Safety of Using Medical Devices: Technovigilance corresponds to the essential regulatory framework in this matter. This standard represents a major step forward in strengthening medical device regulation, specifically at the post-marketing surveillance stage.
Today in the national congress (Senate) the new modification of the current law of medicines and supplies (Law 20.724) is discussed, in this article Medical Devices makes a very special mention to normalize its regulation in Chile, but without mentioning the increase of products subject to regulation.