Medical Device Registration and Approval in Uruguay
General country-specific regulatory information is provided on this page for medical device registration and approval in Uruguay.
Last updated on November 23rd, 2021.
Medical Device Regulations and Classification in Uruguay
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. IVD devices are in a separate class.
TIMEFRAME: The registration process takes 8-12 months.
LICENSE VALIDITY: Licenses issued in Uruguay expire after five years.
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