This post will tell you more about medical device regulations in Uruguay.
The institution responsible for regulating medical devices in Uruguay is the Ministerio de Salud Publica (MSP). Medical devices in Uruguay are categorized into six classes (Category 1 to Category 6) based on their risk.
As Uruguay is a full member of South American trade bloc Mercosur, all medical devices on or entering the Uruguayan market are required to be compliant with Mercosur guidelines. There are harmonized medical device resolutions that have been established by the Mercosur member countries. These resolutions include guidelines regarding the training of the inspectors, GMP certification, premarket approval, and post-market surveillance.
All medical devices marketed in Uruguay must be compliant with Mercosur resolutions and MSP regulations. While MSP states that the review timeframe for medical devices is about 6 months, the process typically can take longer, with the average waiting time sitting at around 10 to 12 months. It is also important to note that the length of the registration process is dependent on the risk associated with the device and is longer for higher class (i.e. more risky) medical devices. Medical device registration certificates expire after 5 years, and if a manufacturer intends to continue to market their device in Uruguay, they must apply for renewal.
All medical devices are required to meet quality assurance standards. Foreign manufacturers must appoint an Authorized Representative in order to be able to market their devices in Uruguay. Manufacturers should also provide a Certificate of Free Sale (CFS) from their product’s country of origin and detailed technical information for the device. More information on receiving marketing authorization in Uruguay has been detailed in Decree 3/008 (the document is written in Spanish).
MSP also provides information on the fees associated with authorization. For medical devices, the total fee is equal to 30 Readjustable Units (USD $1,200).
Monitoring and Compliance Assessment
MSP is also responsible for further medical device monitoring and compliance assessment. MSP achieves this by collaborating with the experts involved in carrying out clinical testing.
MSP may make on-site visits at any time in order to ensure that all operation procedures are compliant with current regulations. In case of any issues with compliance, MSP is empowered to issue a product confiscation, revocation of the registration approval, suspension of all activities, and the enactment of sanctions. Sanction amounts may vary from 30 Readjustable Units to 1000 Readjustable Units (or USD $1,200 to USD $35,000).
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