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Ecuador's National Health Regulatory Agency (ARCSA) has introduced on the 31st of March 2026 new certification requirements for pharmaceutical and medical device establishments, focusing on Good Storage, Distribution, and Transport Practices (BPA/BPD/BPT). The update also includes stricter notification processes for the outsourcing of these services, aiming to bolster safety and regulatory compliance.

Under the new guidelines, businesses involved in the storage, distribution, and transportation of medical products, including pharmaceuticals and devices, must meet rigorous standards to obtain and maintain their certifications. This includes the need for secure, temperature-controlled storage, especially for high-risk products such as controlled substances.

The regulations also require businesses to notify ARCSA within 30 days when outsourcing any of these critical services. These notifications ensure that all subcontractors meet the same high standards required for certification.

For businesses handling controlled substances, additional measures have been mandated, including restricted access to storage areas and certified transportation vehicles to ensure safety during transit.

The certification, valid for three years, will be subject to periodic inspections. Non-compliance could lead to severe penalties, including the suspension or revocation of certifications, which would directly affect the ability to operate within Ecuador's pharmaceutical and medical device sectors.

ARCSA's continuous oversight will include checks on compliance with the new standards, particularly in the handling of sensitive products. For further information you can find the Guideline (in Spanish) here.