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.
April 2, 2025
Approximately 5 minutes
ANSM's Mission: Monitoring the Medical Device Lifecycle and Market Surveillance in France
ANSM's Mission: Ensuring Medical Device Safety in France
The Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), as the French national competent authority, is primarily mandated to ensure that the benefit-risk balance for all health products, including medical devices (MDs) and in vitro diagnostic devices (IVDs), remains positive throughout their entire lifecycle.
1. Market Surveillance and Vigilance
ANSM’s evaluation and market control activities are central to patient safety. This surveillance encompasses two key areas:
- Vigilance System: The centralisation and assessment of incident reports. This system is known as Medical Device Vigilance for MDs and Reactovigilance for IVDs. Reports come from healthcare professionals, patients, and users.
- Proactive Control: ANSM’s monitoring is not limited to reported incidents. It actively conducts conformity checks through manufacturers’ market launch notices, clinical trial/advertising applications, and laboratory controls. The evaluation can include reviewing the manufacturer's technical documentation and clinical data.
2. Market Listing and Identification
To support effective market surveillance, ANSM requires mandatory notification:
- French Manufacturers: Manufacturers of Class I devices and custom-made devices based in France must submit a compulsory declaration of their activity.
- Other Market Players: Manufacturers, agents, and distributors of other classes must also notify the ANSM prior to market release in France, which helps identify devices and market players operating in the country.
3. Quality and Advertising Control
ANSM also regulates specific aspects of device deployment:
- Quality Control: ANSM defines quality control standards for medical devices, initially focusing on devices emitting ionising radiation. It relies on accredited independent bodies to verify on-site compliance with these standards.
- Advertising Control: Advertising for certain MDs/IVDs that pose a significant health risk requires prior approval from ANSM, which is granted for 5 years, subject to CE marking certificate validity. Retrospective control applies to other advertising.
4. Enforcement and Sanctions
In the event of non-compliance, ANSM possesses significant enforcement authority, including the power to:
- Order the manufacturer to take corrective measures.
- Notify Notified Bodies and other competent authorities across Europe.
- Take measures suspending or banning devices from the French market.
- Implement a system of financial sanctions.
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
Medical Device Registration in France: Compliance with EU MDR and ANSM National Listing
France's medical device regulation is governed by the EU MDR. All devices require a **CE Mark** and must be registered locally with the national competent authority, the **ANSM**. Foreign manufacturers require an **EU Authorized Representative** to achieve market access.
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.