The ANMAT announced that the electronic traceability system for Medical Devices has been activated, following art.1 of the ANMAT Disposition N. 2303/14.
The system is destinated to medical device registration holders (distributors/manufacturers).
The device included in the Disposition are:
– defibrillators/cardioverters;
– electric cochlear stimulators (cochlear implants);
– intraocular lens;
– cardiac pacemakers;
– breast implants;
– coronary vascular endoprostheses (stents);
– hip prostheses;
– vertebral prostheses.
The system can be used to perform the following operations:
– agent registration;
– product registration;
– CUFE requests (establishment code).
source1: http://www.anmat.gov.ar/comunicados/Comunicado_Trazabilidad_PM.pdf
source2: http://productosmedicos.servicios.pami.org.ar/
