Authority: National Agency for Health Regulatory Control and Surveillance (ARCSA)

Request Source: Regulation

Data Carrier: GS1-128 / GS1 Data Matrix

Detail: Traceability studies in Ecuador started in 2020. Conducting the studies, ARCSA has phased the transition to traceability for medicinal products and has given a different date for each phase. The deadline for the products traceability is determined as May 2024. However, with the decree published on January 16, 2022, Ecuador’s previous regulation on the traceability of pharmaceuticals and medicinal products was repealed. Details of the new regulations are expected to be published.

• GS1 Standards (Proposed)

Coding Requirements:
AI(10) – Batch/Lot, AI(17) – Expiration Date
AI(01) – GTIN, AI(21) – Serial Number

Links:

https://interamericancoalition-medtech.org/wp-content
https://mdrc-consulting.com/ecuador-medical-device-registration-guide-en/