By Stewart Eisenhart, Emergo Group
Argentina’s medical device market regulator ANMAT has published its latest annual maintenance fee schedule (link in Spanish) for medical device registrations for 2012.
All manufacturers with both commercialized and non-commercialized devices registered in Argentina must pay the fee.
ANMAT announces new registration maintenance fees every year, and levies them retroactively for the previous year. Fee amounts are determined by device classification as well as whether a device has been commercialized in the country.
For commercialized devices with ANMAT registrations valid during 2012, regulators have assigned the following fees:
Class I: roughly USD 70
Class II: roughly USD 100
Class III: roughly USD 130
Class IV: roughly USD 180
Fees for medical devices registered with ANMAT but not commercialized in Argentina are:
Class I: roughly USD 55
Class II: roughly USD 80
Class III: roughly USD 100
Class IV: roughly USD 160
Any company holding medical device registration in Argentina should plan accordingly.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.