ARTICLE SUMMARY:
Each month in Global Spotlight we provide market access facts from the country highlighted on the cover of Market Pathways' print issue. The October 2025 cover features the Palais Bourbon, home of the French National Assembly.
Regulation 
Authority: National Agency for the Safety of Medicines and Health Products (ANSM)
Key Leader: Catherine Paugam-Burtz, MD, Director General, ANSM
Point of Interest
ANSM urges firms to register CE marked devices in EUDAMED rather than the French national database, even though the EU does not currently mandate registration in the Union-wide database.
Reimbursement
Authority: National Authority for Health (HAS)
Key Leader: Jean Lessi, Director General, HAS
Points of Interest
- Hospital procedures are paid via a DRG system.
- Devices can qualify for add-on reimbursement based on HAS technology assessments.
- HAS administers three accelerated device payment paths with streamlined evidence requirements: Forfait Innovation to support evidence development for innovative devices; PECT transitional coverage for devices that target rare or serious conditions; and PECAN transitional coverage for digital therapeutics and remote monitoring devices.
More Resources
- ANSM has posted a detailed English-language summary of its authorities and activities, including tracking new devices and overseeing advertising, in the context of the EU Medical Device and IVD Regulations.
- Market Pathways spotlighted two recent clinical assessment guidelines published by HAS for the PECAN program and the traditional reimbursement route for remote monitoring services LATM in the latest edition of Docs of the Month.
- In an October 2024 article in the journal Health Policy, researchers published a review of reforms and outcomes of early access programs for medical devices in France from 2015 to 2022.
