Navigating Chile's Technovigilance Maze: A Pure Global Breakdown of Resolution 1618/2020 for MedTech Market Access in LATAM

In this episode of LATAM MedTech Insights, we provide a detailed analysis of Chile's Resolution Exenta No. 1618/2020, a landmark regulation that established a strict technovigilance framework for medical devices. We dissect the specific reporting obligations, mandatory timelines, and the critical role of the in-country legal representative. This session moves beyond theory to explore the practical challenges and common mistakes foreign manufacturers face when dealing with the Chilean health authority (ISP). We unpack the nuances of identifying trends from seemingly minor incidents and explain how failure to comply can lead to significant regulatory penalties and loss of market access. **What You’ll Learn:** * What is the precise definition of a "reportable adverse event" under Chilean law? * Are you aware of the crucial 10-day vs. 30-day reporting deadlines? * How can a series of minor device malfunctions escalate into a major compliance issue? * Why is your local Chilean representative absolutely essential for successful technovigilance reporting? * What are the most common reporting errors that foreign companies make with the ISP? * How can you differentiate between an isolated incident and a reportable trend? * What are the documentation expectations for an initial adverse event report versus a final one? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. Let us be your local representative and navigate complex regulations for you. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.