: 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. AUTHORIZED REPRESENTATIVE:
To register a medical or IVD device with the Uruguayan authorities, a manufacturer must either have an office in Uruguay or appoint a local distributor.
Last updated on March 17 2015.
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