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.

Other South American Countries: Argentina, Brazil, Colombia, Ecuador, Peru, Uruguay, Venezuela