France Medical Device Registration
Important Notes
- National Database Registration: After CE marking, medical devices must undergo mandatory national registration in the "SI-DEP" database managed by the French National Agency for Medicines and Health Products Safety (ANSM), obtaining a SIR identifier.
- French Language Labeling & Patient Info: All labels, IFUs, patient leaflets, and advertising must be in French, using official terminology, with clear hierarchy and public-friendly information.
- Economic Operator Identification: Manufacturers, ARs, etc., must register in EUDAMED for an SRN and appoint a "Person Responsible for Product Safety" (PRS) in France.
- Pricing & Reimbursement Assessment: High-risk medical devices must undergo clinical benefit (SMR) and added benefit (ASMR) assessment by the French National Authority for Health (HAS), followed by price & reimbursement rate (TFR) negotiation with the CEPS.
- LPPR Listing & Public Procurement: Reimbursable medical devices and aids must be listed on the "List of Reimbursable Products and Services" (LPPR) and comply with public procurement platform rules for hospital purchases.
- Advertising & Transparency Law: All promotion to HCPs must comply with the "Bertrand Law" on transparency, publicly disclosing all payments and benefits.
France Specific Requirements
- Clinical Value-Centric Assessment: HAS SMR/ASMR ratings directly determine reimbursement level and commercial value for medical devices; the rating process is strict and favors French data.
- Strong National Cost-Control Mechanism: CEPS price negotiations are based on strict budget impact analysis and international price comparisons, aiming to control national health insurance (Assurance Maladie) expenditure on medical devices.
- Centralization & Regionalization: National rules for access & reimbursement, but Regional Health Agencies (ARS) handle budget allocation and hospital procurement, creating a "national pricing, local purchasing" model for medical devices.
- Special Support for Innovation: Incentives like accelerated assessment, early temporary authorization for use (ATU), and premium pricing exist for innovative medical devices with high added benefit (ASMR I-III).
- Unique Pharmacy & Distribution Network: Pharmacies play a key role in retailing medical devices; distribution is dominated by a few monopolistic wholesalers, making channel partnerships crucial.
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)
- French Labeling and Instructions for Use
- ANSM National Registration and UDI Allocation
- EU Authorized Representative Appointment
- Clinical Investigation Approval (if applicable)
- Post-Market Surveillance Plan
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Notified Body Assessment
- EU Authorized Representative Appointment
- ANSM Registration Submission
- UDI Allocation Completion
Registration Timeline
12-24 months
Official Fees
€5,000 - €50,000
Service Fees
$25,000 - $80,000
Regulatory System Overview
ANSM
French National Agency for the Safety of Medicines and Health Products
Responsible for medical device registration approval, quality supervision, post-market safety monitoring, and market regulation. Operates as the supreme health product regulatory authority under the French Ministry of Health.
HAS
French National Authority for Health (Haute Autorité de Santé)
Responsible for clinical benefit (SMR) and added benefit (ASMR) assessment of medical devices, determining reimbursement eligibility and pricing negotiation basis for high-risk devices.
CEPS
Economic Committee for Health Products (Comité Économique des Produits de Santé)
Responsible for price negotiation and reimbursement rate setting for reimbursable medical devices, ensuring national health insurance expenditure control.
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 French 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
ANSM Registration
Submit medical device national registration and UDI information to ANSM