ABSTRACT
Regulation of medical devices in Argentina derives its statutory authority from a 1985 decree of the Ministry of Health and Social Action. Decree No. 2,505/85 established the need for regulations to cover certain technical aspects that contribute to a better handling of the activities covered by the decree. In addition, the regulations are expected to enable more efficient health oversight of these activities and of the products involved. The regulations foreseen by Decree No. 2,505/85 were published as Resolution 255/95.
