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.