Procurement Dynamics and the National HTA Program
The purchasing of medical devices in Italy is governed by a combination of regional autonomy and national strategic oversight.
Public Tendering and Legislative Decree 36/2023 Most medical devices enter the public sector via "Open Procedures" and "Framework Agreements." Regional agencies, such as A.S.L. Napoli or Azienda Sanitaria dell'Alto Adige, issue massive tenders for everything from urology devices to anti-decubitus systems. The process emphasizes Preventive Transparency, allowing companies to see upcoming needs well in advance.
The National HTA Program (2026–2028) The National Agency for Regional Health Services (AGENAS) manages the Health Technology Assessment (HTA) program. This program evaluates:
Clinical Impact: Does the new technology provide a measurable benefit over existing treatments?
Economic Impact: What is the long-term cost-saving potential for the National Health Service (SSN)?
Prioritization: Technologies are ranked based on shared criteria, ensuring that high-value innovations like robotic surgical systems receive faster paths to reimbursement.