Italy Product Registration & Certification
Important Notes
- National Registration & Classification: After CE marking, medical devices must be registered and nationally classified in the Italian Ministry of Health's National Database of Medical Devices (Repertorio DM).
- Italian Language Labeling & Documentation: All product labels, instructions for use, and technical summaries must be in Italian, with translations accurate and compliant with official terminology.
- Authorized Representative & Local Responsible Person: Non-EU manufacturers must appoint an Italian Authorized Representative; high-risk devices also require an in-country "Technical Person Responsible" (Responsabile Tecnico).
- Pricing & Reimbursement Application: Medicines and some high-risk devices must apply to the Italian Medicines Agency (AIFA) for pricing and inclusion in the National Reimbursement List (Prontuario), involving complex HTA and price negotiations.
- Public Procurement Registration (CAM): Products must comply with Minimum Environmental Criteria (Criteri Ambientali Minimi, CAM) and register on public procurement platforms (e.g., Consip) to participate in public hospital tenders.
- Advertising Authorization & Self-Regulation: Medicine advertising requires pre-authorization from AIFA; advertising for devices and cosmetics must follow self-regulatory codes, with claims backed by detailed scientific literature.
Italy specific Requirements
- Dual-Layer Central & Regional Governance: National government sets rules and reimbursement lists, but the 20 Regions have high autonomy in health budgets, procurement, and service organization, creating a fragmented market.
- Public Procurement-Dominant Payment System: The National Health Service (SSN) is the main payer. Reimbursement listing is critical but faces strict cost-control and price reduction pressures.
- High Demand for HTA Evidence: AIFA's HTA assessments are particularly rigorous, emphasizing real-world data (RWD) and pharmacoeconomics, with a preference for Italian Post-Authorization Safety Studies (PASS).
- Complex Distribution & Logistics Network: The market relies on multi-tiered distributor/subcontractor networks; building relationships with large GPOs and Regional Health Authorities (ASL) is key.
- Culture of Tradition & Innovation: The system respects traditional clinical practices but is rapidly increasing acceptance of breakthrough therapies and digital health solutions (e.g., telemedicine).
Medical Devices Registration
Regulatory Requirements
- CE Marking Certification (EU MDR 2017/745)
- Classification Management per MDR Regulations (Class I, IIa, IIb, III)
- Complete Technical Documentation and Clinical Evaluation Report
- Quality Management System (EN ISO 13485:2016)
- Italian Labeling and Instructions for Use
- Ministry of Health Database Registration (Repertorio DMD)
- EU Authorized Representative Appointment
- UDI System Implementation
- Post-Market Surveillance Plan
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Notified Body Assessment
- EU Authorized Representative Appointment
- Ministry of Health Registration Submission
- Database Entry Completion
Registration Timeline
12-24 months
Official Fees
€4,000 - €45,000
Service Fees
$22,000 - $65,000
Regulatory System Overview
Italian Ministry of Health
Italian Ministry of Health (Ministero della Salute)
Responsible for regulatory approval, database management, post-market surveillance of medical devices, food supplements, cosmetics, and other health products. Serves as the supreme health product regulatory authority in Italy.
ISS
Italian National Institute of Health (Istituto Superiore di Sanità)
Responsible for technical evaluation, scientific research, and safety assessment of medical devices, pharmaceuticals, and food supplements, providing scientific support for Ministry regulatory decisions
ICQRF
Central Inspectorate for Quality Protection and Fraud Repression of Food Products
Responsible for quality supervision, market inspection, and labeling compliance regulation of food, food supplements, and agricultural products, combating commercial fraud practices
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification according to EU MDR regulations (Class I, IIa, IIb, III)
Technical Documentation Preparation
Prepare complete Italian technical documentation including clinical evaluation, performance verification, risk management
Notified Body Assessment
Undergo conformity assessment and quality management system audit by EU Notified Body
EU Authorized Representative
Appoint authorized representative within EU responsible for regulatory compliance
Ministry of Health Registration
Submit medical device database registration (Repertorio) to Italian Ministry of Health
Cosmetics Registration
Regulatory Requirements
- CPNP Notification (Cosmetic Products Notification Portal)
- Product Information File (PIF) - Italian Version
- Cosmetic Product Safety Report (CPS)
- Good Manufacturing Practice (ISO 22716)
- Italian Labeling Requirements
- Italy Specific Ingredient Restrictions
- Nanomaterial Notification (if applicable)
- Responsible Person Appointment
Main Process
- Safety Assessment Completion
- Product Information File Preparation
- Responsible Person Appointment
- CPNP Notification Submission
- GMP System Establishment
- Italy Compliance Check
Registration Timeline
3-5 months
Official Fees
€0 - €2,500
Service Fees
$5,000 - $15,000
Regulatory System Overview
Italian Ministry of Health
Italian Ministry of Health (Ministero della Salute)
Responsible for regulatory approval, database management, post-market surveillance of medical devices, food supplements, cosmetics, and other health products. Serves as the supreme health product regulatory authority in Italy.
ISS
Italian National Institute of Health (Istituto Superiore di Sanità)
Responsible for technical evaluation, scientific research, and safety assessment of medical devices, pharmaceuticals, and food supplements, providing scientific support for Ministry regulatory decisions
ICQRF
Central Inspectorate for Quality Protection and Fraud Repression of Food Products
Responsible for quality supervision, market inspection, and labeling compliance regulation of food, food supplements, and agricultural products, combating commercial fraud practices
Cosmetics Registration Process
Safety Assessment
Complete cosmetic product safety report (CPS) by qualified safety assessor
PIF Preparation
Prepare complete product information file (Italian version)
Responsible Person Appointment
Appoint responsible person in Italy for product compliance
CPNP Notification
Submit product information through EU Cosmetic Products Notification Portal
Italy Compliance
Ensure compliance with Italy specific ingredient restrictions and labeling requirements
Food Supplements Registration
Regulatory Requirements
- Italian Ministry of Health Notification (Notifica Ministero della Salute)
- Ingredient Compliance Assessment (Italy Permitted Ingredient Lists)
- Nutrition and Health Claims Compliance
- Italian Labeling Requirements
- Good Manufacturing Practice Certification
- Ingredient Specifications and Purity Proof
- Stability Study Data
- ICQRF Declaration Documents
Main Process
- Ingredient Compliance Assessment
- Technical Documentation Preparation
- Ministry of Health Notification Submission
- Labeling Review Preparation
- ICQRF Compliance Preparation
Registration Timeline
4-8 months
Official Fees
€400 - €4,500
Service Fees
$6,000 - $18,000
Regulatory System Overview
Italian Ministry of Health
Italian Ministry of Health (Ministero della Salute)
Responsible for regulatory approval, database management, post-market surveillance of medical devices, food supplements, cosmetics, and other health products. Serves as the supreme health product regulatory authority in Italy.
ISS
Italian National Institute of Health (Istituto Superiore di Sanità)
Responsible for technical evaluation, scientific research, and safety assessment of medical devices, pharmaceuticals, and food supplements, providing scientific support for Ministry regulatory decisions
ICQRF
Central Inspectorate for Quality Protection and Fraud Repression of Food Products
Responsible for quality supervision, market inspection, and labeling compliance regulation of food, food supplements, and agricultural products, combating commercial fraud practices
Food Supplements Registration Process
Ingredient Compliance Assessment
Evaluate all ingredients for compliance with Italy permitted ingredient lists
Technical Documentation Preparation
Prepare Italian technical documents including safety evidence, quality specifications
Ministry of Health Notification
Submit food supplement notification application to Italian Ministry of Health
Labeling Review
Ensure labeling fully complies with Italian labeling regulations
Claims Compliance
Review all health claims for compliance with Italian authorized lists