The Ministry of Public Health (MSP) is the competent authority for medical and in-vitro diagnostic devices in Uruguay. All products must be registered with MSP before being placed into the Uruguayan market. Medical devices are divided into four classes (I, II, III and IV), based on the risk level.

To register a medical or IVD device with the Uruguayan Authority, the manufacturer must have an office in Uruguay or appoint a local distributor. Such office or distributor must comply with the GMPs and be authorized by MSP to import devices. Our country specific (*) regulatory services in Uruguay include:

Medical Device specific regulation strategy reports, Medical Device Registration with MSP, MSP Technical documents Preparation, GMP audit compliance and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Uruguay!

(*) Uruguayan Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat service.