New Laws for Medical Device Registration Imminent in Argentina
A new law affecting registration of medical devices for sale in Argentina will likely go into effect sometime in 2013.
The Traceability System and Technical Aptitude Verification for Active Medical Devices in Health Institutions (PDF link in Spanish) law will increase requirements particularly for Class II Active and higher-risk devices.
Foreign manufacturers registering with Argentinean market regulator ANMAT will have to provide all documentation pertaining to technical support, installation, maintenance and service in Spanish. Furthermore, these materials will need to be supplied to all institutions where those devices are utilized.
Foreign manufacturers’ authorized representatives in Argentina will also bear responsibility for these new requirements, according to the law.
Emergo Group will provide further details on upcoming changes to medical device registration in Argentina as they become available.