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.

 

Other South American Countries: Argentina, Brazil, Chile, Colombia, Ecuador, Peru, Venezuela

Find regulatory information from 140+ countries here

Tell me more

JUST SAY WHEN!

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 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!

Start my free trial
Arazy Group Youtube

Ready to Get Started?

Tell Us What You Need
Attend a REGTalk
Schedule a Product Tour