Italy is a pivotal European market with a mixed public-private healthcare system and stringent regulations demanding meticulous compliance from global manufacturers.
Drug regulations are overseen by the Agenzia Italiana del Farmaco (AIFA), while medical devices follow EU directives through the Italian Ministry of Health and competent authorities. Medwisdom LifeScience specializes in navigating this complex regulatory landscape, providing expert Regulatory Affairs guidance to foreign manufacturers. We assist in deciphering Italian requirements, developing strategic approaches for compliant market authorizations, streamlined submission procedures, and comprehensive support tailored to entering and maintaining long-term compliance in the Italian market.
Get Italy Compliance Support
Expert guidance on Italian regulatory requirements, strategic planning, and market entry strategies for medicinal products and medical devices.
Comprehensive regulatory intelligence, submission support, and ongoing compliance monitoring with AIFA and Ministry of Health.
Full assistance with CE marking for medical devices, Notified Body interactions, and conformity assessment under EU MDR/IVDR.
Preparation and optimization of NeeS and eCTD dossiers for national, MRP, DCP, and centralized procedures.
Post-approval changes, renewals, variations, and full lifecycle support for sustained compliance.
Pharmacovigilance system setup, local QPPV support, PSUR/PBRER submissions, and signal detection in Italy.
Support for MRP, DCP, centralized procedures, national registrations, and ongoing maintenance with AIFA.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Italy — from strategic planning and registration to lifecycle and pharmacovigilance success.
Contact Our Italy Regulatory Experts