Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
Emergo by UL
USA, Canada, Brazil, Australia, China, Hong Kong, Taiwan, India
A dedicated partner for medical device and IVD manufacturers, we offers deep local regulatory expertise through its offices in over 20 global locations. Services include product registration, human factors research, clinical strategy, and local in-country representation to ensure rapid, compliant market access worldwide.
June 2, 2025
Approximately 5 minutes
Italian Market Access: The Importance of the Repertorio and SSN Procurement
Italian Medical Device Market Access: The Role of the Repertorio
Gaining access to the Italian medical device market is a two-tiered process: achieving the pan-European CE Mark and fulfilling crucial national requirements, primarily mandated by the Ministero della Salute (Ministry of Health).
1. Mandatory National Database Registration (Repertorio)
The most significant national hurdle is registration in the Italian Medical Devices Database:
- The Repertorio: This national database, officially called the Repertorio dei Dispositivi Medici, is where all medical devices distributed in Italy must be registered by the manufacturer or their EU Authorized Representative (AR).
- Mandatory for All: Registration is generally mandatory for all device classes, but it is absolutely critical for commercial success, as devices must be registered to be sold to the Italian National Health Service (SSN). Since the SSN is the largest purchaser of medical devices, registration directly impacts sales viability.
- Non-EU Manufacturer Responsibility: Non-EU manufacturers must designate an AR who is responsible for completing and maintaining the Repertorio registration data, ensuring the device remains compliant.
2. Language and Local Compliance
Italy enforces strict national language and safety requirements:
- Italian Language: All safety information, including Instructions for Use (IFUs), labeling, and technical literature intended for the end-user, must be accurately translated and presented in the Italian language.
- Fiscal Requirements: Importers and distributors must comply with national fiscal and VAT registration requirements.
3. Vigilance and Market Oversight
The Ministry of Health uses the Repertorio data for robust post-market oversight:
- Vigilance System: The AR must ensure that any serious adverse events occurring in Italy are reported promptly to the Ministero della Salute's vigilance system.
- Market Surveillance: The Ministry actively monitors the Italian market, cross-referencing devices sold with the Repertorio data to ensure traceability and compliance, especially for high-risk devices.