General country-specific regulatory information is provided on this page for medical device registration and approval in Uruguay.
We review our Regulatory Information frequently; please check back often for updates
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.
For detailed device-specific compliance information for each market, including Uruguay, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
