ARCSA mandates the implementation of a Unique Traceability Code (CUT) for medicines and medical devices. For medical devices specifically, this code aligns with the Universal Device Identification (UDI) system established by the International Medical Device Regulators Forum. The CUT/UDI must include essential identifying information such as the Global Trade Item Number (GTIN), batch/lot number, expiration date, and for implantable devices, a mandatory serial number.

Ecuador's pharmaceutical regulations require detailed data capture throughout the supply chain journey. All logistics movements must be meticulously documented, including quarantine, release, distribution, reception, and delivery to patients. The system also tracks product cancellations, losses, thefts, transfers, expirations, returns, withdrawals, and clinical trial products. This robust reporting framework enables comprehensive oversight of pharmaceutical products from manufacture to patient.

The ARCSA regulations impose specific labeling requirements for pharmaceutical products. The CUT must be printed using a two-dimensional barcode on the packaging (primary and/or secondary) and must be placed in a visible location. When packaging size permits, human-readable information including GTIN, expiration date, lot number, and serial number must also be displayed. In cases where printing on packaging is not feasible, tamper-evident stickers or adhesives with CUT are permitted.

ARCSA manages a centralized traceability database that serves as the backbone of Ecuador's pharmaceutical oversight system. This sophisticated database stores all records related to product logistics and enforces strict access controls, permitting only authorized personnel to interact with the system. It is designed to provide alerts for irregularities such as duplicate codes or unauthorized operations, while ensuring data security and privacy, particularly regarding patient information.