Thursday, November 7, 2013

New technical director requirements for some medical devices in Argentina

New technical director requirements for some medical devices in Argentina- massdevice: Emergo Group has learned that recent changes to Argentinean medical device regulator ANMAT requirements for medical device registration holders, distributors and importers has created a legal issue between pharmacists and biomedical engineers. Previously, ANMAT required registration holders to have biomedical engineers on staff to act as technical directors for medical devices sold in Argentina. Now, however, regulators are requiring registrants to have pharmacists act as technical directors for sterile and implantable devices, and biomedical engineers for all other device types.