REGULATORY AUTHORITY: Medical devices are regulated by the ISP (Instituto de Salud Pública or Public Health Institute).
CLASSIFICATION SYSTEM: Medical Devices are classified according to the risk I, II,III, VI and IVD to the risk A,B, C and D.
TIMEFRAME: The approval process takes 2-3 months.
LICENSE VALIDITY: Licenses issued in Chile are valid until the expiry of the device’s first relevant certificate (FSC, IO 13485, LoA).
AUTHORIZED REPRESENTATIVE: A local representative must be appointed by the manufacturer, “Authorized Representative” should receive and accept a written mandate in the form of a power of attorney (letter of designation) or signed contract from a legal manufacturer, located outside the country, to act on behalf of the latter in relation to specific tasks concerning its health obligations towards the Institute of Public Health.