France Product Registration & Certification
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: Drugs and high-risk 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 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; 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.
- 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.
- Special Support for Innovation: Incentives like accelerated assessment, early temporary authorization for use (ATU), and premium pricing exist for innovative products 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 registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, pharmaceuticals, and biological products. Operates as the supreme health product regulatory authority under the French Ministry of Health.
DGCCRF
Directorate General for Competition, Consumer Affairs and Fraud Control
Responsible for market surveillance of food, cosmetics, consumer products, protecting consumer rights, enforcing labeling and advertising regulations, and combating commercial fraud
ANSES
French Agency for Food, Environmental and Occupational Health & Safety
Responsible for risk assessment, scientific research, and safety evaluation of food, food supplement, and cosmetic ingredients, providing scientific basis for regulatory decisions
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
Cosmetics Registration
Regulatory Requirements
- CPNP Notification (Cosmetic Products Notification Portal)
- Product Information File (PIF) - French Version
- Cosmetic Product Safety Report (CPS)
- Good Manufacturing Practice (ISO 22716)
- French Labeling Requirements
- France 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
- France Compliance Check
Registration Timeline
3-6 months
Official Fees
€0 - €3,000
Service Fees
$6,000 - $18,000
Regulatory System Overview
ANSM
French National Agency for the Safety of Medicines and Health Products
Responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, pharmaceuticals, and biological products. Operates as the supreme health product regulatory authority under the French Ministry of Health.
DGCCRF
Directorate General for Competition, Consumer Affairs and Fraud Control
Responsible for market surveillance of food, cosmetics, consumer products, protecting consumer rights, enforcing labeling and advertising regulations, and combating commercial fraud
ANSES
French Agency for Food, Environmental and Occupational Health & Safety
Responsible for risk assessment, scientific research, and safety evaluation of food, food supplement, and cosmetic ingredients, providing scientific basis for regulatory decisions
Cosmetics Registration Process
Safety Assessment
Complete cosmetic product safety report (CPS) by qualified safety assessor
PIF Preparation
Prepare complete product information file (French version)
Responsible Person Appointment
Appoint responsible person in France for product compliance
CPNP Notification
Submit product information through EU Cosmetic Products Notification Portal
France Compliance
Ensure compliance with France specific ingredient restrictions and labeling requirements
Food Supplements Registration
Regulatory Requirements
- French Public Health Code Compliance
- Ingredient Compliance Assessment (ANSES Lists)
- Nutrition and Health Claims Compliance
- French Labeling Requirements
- Good Hygiene Practice Certification
- Ingredient Specifications and Purity Proof
- Stability Study Data
- DGCCRF Declaration Documents
Main Process
- Ingredient Compliance Assessment
- Technical Documentation Preparation
- Labeling Review Preparation
- DGCCRF Declaration
- Market Access Completion
Registration Timeline
4-8 months
Official Fees
€500 - €5,000
Service Fees
$7,000 - $20,000
Regulatory System Overview
ANSM
French National Agency for the Safety of Medicines and Health Products
Responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, pharmaceuticals, and biological products. Operates as the supreme health product regulatory authority under the French Ministry of Health.
DGCCRF
Directorate General for Competition, Consumer Affairs and Fraud Control
Responsible for market surveillance of food, cosmetics, consumer products, protecting consumer rights, enforcing labeling and advertising regulations, and combating commercial fraud
ANSES
French Agency for Food, Environmental and Occupational Health & Safety
Responsible for risk assessment, scientific research, and safety evaluation of food, food supplement, and cosmetic ingredients, providing scientific basis for regulatory decisions
Food Supplements Registration Process
Ingredient Compliance Assessment
Evaluate all ingredients for compliance with ANSES permitted lists
Technical Documentation Preparation
Prepare French technical documents including safety evidence, quality specifications
Labeling Review
Ensure labeling fully complies with French labeling regulations
Claims Compliance
Review all health claims for compliance with French authorized lists
DGCCRF Preparation
Prepare complete declaration documents for market surveillance inspections