June 10, 2025 – The rapid increase in the number of manufacturers and importers of medical equipment in Iran has placed significant pressure on administrative processes, leading to delays in regulatory approvals. Currently, over 2,000 manufacturers and nearly as many importers are active in the country, with more than 4,000 companies regularly utilizing official health sector platforms for their services.

This surge in active companies, combined with the diversity of models, components, raw materials, and specialized needs, has made the review of regulatory files time-consuming. The situation is compounded by additional factors such as price-setting procedures, after-sales service follow-ups, and responding to third-party inquiries, all of which increase the workload for regulatory staff.

A key bottleneck is the time required for product testing in laboratories affiliated with the Food and Drug Administration, which can naturally extend the approval process. Experts suggest that improving software infrastructure and revising administrative procedures could help accelerate the licensing process. Investors and manufacturers, having established production lines and employed skilled personnel, expect swift licensing to bring their products to market.

Accurate and complete submission of documentation at the time of application is emphasized as a practical step to prevent delays and expedite file reviews. The continued growth of the sector makes it essential to reform regulatory frameworks to support both innovation and timely access to medical equipment in Iran.