When a medical device is not subject to mandatory health registration in Chile, the ISP Background Review may serve as a technical and commercial support tool. Learn when it applies, what its scope is, and how to integrate it into a market-entry strategy.
Exempt Decree No. 25 of 2026 brings 39 categories of medical devices and IVDs under Chile’s mandatory health registration framework. We analyze the products covered, implementation timelines, and regulatory implications for companies operating in LATAM.