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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Uruguay, to expedite the preparation of your medical device or IVD registration application.
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.
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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