MEDICAL DEVICE REGISTRATION AND APPROVAL IN Uruguay

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 update: August 2023

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.

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.

 

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And, in less than a minute, you can start your device-specific registration application and a complete country-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform. You can start your product registration right now!

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