ANMAT expand post-market surveillance programs in Argentina

October 31, 2012 by MassDevice

Global Medicine

By Stewart Eisenhart, Emergo Group

Argentinean medical device market regulator ANMAT has launched a TechnoVigilance Program for Medical Devices (PDF document in Spanish) as part of a broader effort among South American regulators to beef up coordinated post-market surveillance systems.

Most recently, ANMAT established requirements that all mammary, hip, knee and spinal implant devices—whether imported or domestic—register under the regulator's TechnoVigilance Program before commercialization in Argentina. Manufacturers of these devices must supply the following information to ANMAT in order to satisfy TechnoVigilance requirements:

Sponsored by Emergo Group
  • Serial and batch numbers
  • Model
  • Manufacturer information
  • Importer information
  • Quantity of device to be released
  • Expiration date
  • Sterile condition
  • Denomination
  • Trademark information

ANMAT has also published an online training document (in Spanish only) for stakeholders affected by the new post-market surveillance requirements.

ANMAT's TechnoVigilance Program follows a broader effort among South American MERCOSUR customs union member countries (Argentina, Brazil, Paraguay, Uruguay and Venezuela) to improve traceability, recall and other post-market processes in their medical device markets.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

Comments

Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp