REGULATORY AUTHORITY: The Ministry of Public Health (MSP) is the competent authority for the regulation of medical and in-vitro diagnostic devices in Uruguay.
CLASSIFICATION SYSTEM: Medical devices are divided into four classes (I, II, III and IV), based on risk level.
TIMEFRAME: The registration process takes 4-6 months.
LICENSE VALIDITY: Licenses issued in Uruguay expire after five years.
AUTHORIZED REPRESENTATIVE: LH is a local legal entity in Uruguay authorized by the Ministry of Health to trade in medical devices. The LH itself is the only one authorized to import.