Sep 29, 2014
Argentina’s medical device market regulator ANMAT has published its latest schedule (link in Spanish) of annual maintenance fees for both new and renewed registrations.
For existing medical device registrations, ANMAT has set the following fees:
For new registrations, slightly higher fees have gone into effect:
Delayed requirements for medical device distributors
In addition, ANMAT has delayed implementation (link in Spanish) of new requirements for device distributors until early 2015. The Good Storage Practice requirements follow ANMAT Provision 6052-2013, which established regulatory requirements for distributors for the first time in 2013 in Argentina.
ANMAT, the Argentinean medical device market regulator, has enacted a new interpretation of the General Law for Medical Devices (document in Spanish) that will affect various components of the country’s device registration process. Specifically, ANMAT Provision 5627-2006 has been replaced by ANMAT Provision 727-2013.