Ecuador strengthens regulations for medical devices, storage and transport

In Ecuador, the regulatory body ARCSA has issued new provisions affecting both medical devices and health-care supplies. Under resolution ARCSA-DE-2024-047-DASP, signed 12 December 2024 and effective June 2025, the country broadens and tightens requirements for establishments involved in storage, distribution and transport of medicines and medical devices. The announcement was made on 24 January 2025. 

Key changes include: (i) enhanced technical documentation for establishment certification, (ii) traceability and control obligations for imported devices, (iii) specific cold-chain management obligations where applicable, (iv) a transitional period allowing small/medium enterprises to be exempt from inspection fees for the first three years. The aim is to align Ecuador with international good-practice standards and reinforce consumer protection for medical-device use. 

For device manufacturers and importers, this means that operating or importing into Ecuador now demands revising logistic contracts, verifying distributor compliance with the new regulation, ensuring transport and storage of imported products match the defined criteria, and updating the import flows so customs and health-surveillance authorities don’t withhold shipments for non-compliance. Operational and logistic costs will rise, but the device-market in Ecuador is strengthened in credibility for quality devices.

Sources:

• “Ecuador Updates Regulations on Good Practices for Storage, Distribution, and/or Transportation for pharmaceutical companies and manufacturers of medical devices for human use.” GPC Gateway, Jan 24 2025. Link