DINAVISA Earns ISO 9001:2015 Certification

DINAVISA formally obtained the international ISO 9001:2015 certification for its Quality Management System, applied to the regulation, control and oversight of medicines in Paraguay. The reported scope includes the evaluation and approval of health registrations, monitoring of clinical pharmacology studies, quality testing, and oversight of facilities and products throughout the commercial chain.

What processes were covered by the certification?

The reported coverage spans several stages of health oversight, from review of registrations to inspection of products and facilities. 1000 Noticias added that this also includes market surveillance, oversight of pharmaceutical facilities, and inspection of products intended for public consumption.

La Tribuna described the certification as a step toward strengthening drug control in Paraguay. Última Hora, meanwhile, said the recognition validates standardized, documented, and traceable procedures, presented as tools to reinforce oversight and increase public safety.

How was the achievement announced, and what support did it receive?

The certification was announced publicly on October 14, 2026, after DINAVISA’s national director delivered the certificate background to President Santiago Peña. MegaCadena reported that the announcement took place during a meeting between Jorge Iliou and Peña at Mburuvicha Róga, and that the certification had been achieved on October 5, 2026.

According to TVS, the process included technical assistance from the United Nations Industrial Development Organization, collaboration from the Paraguayan Industrial Union through SiCalidad Paraguay and SECAP, and funding from the European Union. Coverage also said DINAVISA asked the World Health Organization for an evaluation through the Global Benchmarking Tool.

What is the difference between ISO and the WHO assessment?

Revista Plus clarified that ISO 9001:2015 certification focuses on quality management system requirements, while the WHO GBT assessment is designed to measure specific regulatory capacities. For that reason, DINAVISA’s request does not by itself amount to recognition as a reference regulatory authority.

That distinction matters because the ISO scope confirms the standardization of internal processes, but it does not equal full regulatory validation by the WHO. At the same time, the process before the international body seeks a different assessment, focused on concrete regulatory capabilities.