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Regulation on traceability of medical devices in Argentina

“Medical device traceability is an efficient tool to control products’ transactions in real-time, verify their origins, record the history of their locations and movements along the supply chain, in order to bring safety to patients,” explained Dr. Maximiliano Derecho, Legal Advisor from ANMAT as he discussed the major reasons for building the country’s traceability system. Argentina uses the GS1 standard for product identification: a Global Trade Item Number® (GTIN®) with a serial code, batch/lot number and expiry date.
To achieve a full track and trace system, Dr. Derecho outlined the following:

  • Each agent is identified with a Global Location Number (GLN) and can only transmit events authorised by its licence.
  • The system sends alerts when it detects areas such as code duplication, an unconsolidated shipment or an expired or stolen product that is attempting to be reported.

Read more by downloading this presentation.