Uruguay : Requirements for Medical Devices and In Vitro Medical Devices

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref. : EIC 432/2

28 April 2025

Dear Sirs,

The Uruguayan Government issued Decree No. 498/025 to incorporate the Southern Common Market (Mercosur¹) Common Market Group (GMC) Resolution No. 07/24 into Uruguayan domestic legal regime.  The Resolution sets forth safety and performance requirements for medical devices and in vitro medical devices.

2.For details, traders are advised to consult their importers in Uruguay and/or the above Uruguayan Decree (in Spanish) at: https://www.adau.com.uy/innovaportal/file/20740/1/msp_498.pdf.

3.For enquiries concerning the content of this circular, please contact us at telephone number 2398 5405.

Yours faithfully,

(Dixon FUNG)
for Director-General of Trade and Industry

¹ The Southern Common Market (Mercosur) includes Argentina, Bolivia, Brazil, Paraguay, Uruguay and Venezuela. Membership of Venezuela has been temporarily suspended since 2 December 2016.

Note: While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.