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.
El Decreto Exento N.º 25 de 2026 incorpora 39 categorías de dispositivos médicos y DMDIV al régimen de registro sanitario obligatorio en Chile. Analizamos los productos alcanzados, los plazos de implementación y las implicancias regulatorias para empresas con operaciones en LATAM.
Regulatory Reliance in Chile: A Step Forward in the Evaluation of Biological Medicines The Institute of Public Health of Chile (ISP) has implemented a regulatory reliance mechanism for granting health registrations for biological pharmaceutical products. This procedure, formalized through Exempt Resolution No. E679/25 on January 27, 2025, allows the National Medicines Agency (ANAMED) to use […]