By Stewart Eisenhart, Emergo Group
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.
It is anticipated that Argentinean lawmakers and regulators will revise this new requirement at some point so that biomedical engineers will once again be required to act as technical directors for all medical device types; until officials make that revision, however, manufacturers and their representatives with medical device registrations in Argentina should be aware of these new (albeit temporary) staffing requirements.
In other Argentina medical device market news, ANMAT has come out with new customs codes for medical devices in line with the harmonization goals of Mercosur member countries.
ANMAT has published the new codes on its website.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.