Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
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.
March 2, 2025
Approximately 5 minutes
Medical Device Registration in France: Compliance with EU MDR and ANSM National Listing
France Medical Device Registration Requirements
Medical device market access in France is based entirely on the European Union (EU) regulatory framework, primarily the Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Regulation (EU IVDR 2017/746).
1. Regulatory Authority and National Listing
The national competent authority in France is the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM). While the main device registration is centralized via the EU system (EUDAMED), local French regulation requires device listing and communication to the ANSM.
- Market Oversight: The ANSM is responsible for the regulation of medical devices, including local listing requirements, vigilance, and market surveillance, under the French National Authority for Health.
- Foreign Manufacturers: Manufacturers based outside the EU must appoint an EU Authorized Representative (AR) to act on their behalf to interface with the ANSM and secure market access.
2. Mandatory Conformity (CE Marking)
All medical devices, regardless of classification, must bear the CE Marking to be marketed in France. The required registration route depends on the device's risk classification (Class I, IIa, IIb, III, or Active Implantable Medical Devices - AIMDs).
- Conformity Assessment:
- Low-Risk Devices (e.g., Class I): Can typically use self-certification to obtain the CE Mark.
- Higher-Risk Devices (Class IIa, IIb, III, AIMDs): Require conformity assessment by an EU Notified Body.
- Documentation: Manufacturers must maintain a robust Technical Documentation file and issue a Declaration of Conformity to claim the CE Mark.
3. Key Regulatory Information
- Quality System: Compliance with the internationally recognized quality system standard ISO 13485:2016 is mandatory for all non-Class I (non-sterile, non-measuring) devices.
- License Validity: The registration is valid for 5 years.
- License Transfer: A Change of Registration application is required to transfer a license between parties.
- Local Entities: The local License Holder (the AR, on behalf of the product owner) is responsible for appointing and managing local Importers and Distributors.
Related Articles
Approximately 5 minutes
Medical Device Registration in France: Compliance under the EU MDR and the ANSM
Medical device registration in France is governed by the EU Medical Device Regulation (EU MDR 2017/745). The national competent authority is the **ANSM**. Registration involves obtaining the mandatory **CE Mark** and ensuring data entry into the **EUDAMED** database.
Approximately 5 minutes
ANSM's Mission: Monitoring the Medical Device Lifecycle and Market Surveillance in France
The **ANSM** ensures the safety of medical devices in France by constantly monitoring the **benefit-risk balance** throughout their lifecycle. Its mission includes **market surveillance**, centralizing **vigilance** reports, controlling device advertising, conducting inspections, and enforcing corrective measures for non-compliance.
Approximately 5 minutes
French Medical Device Market Entry Costs: Budgeting for EU MDR Compliance (€50K to €300K)
Entering the French medical device market requires budgeting between **€50,000 and €300,000**, primarily driven by **CE Marking certification fees** and the complexity of the device's classification. Key expenses include Notified Body fees, technical documentation, French translation, and annual **Authorized Representative** costs.