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EUROPE

FRANCE

FRANCE

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Global   >   Europe    
Market Information

France’s healthcare expenditure has increased significantly over the years, with spendings of approximately $6630 per capita on health in 2023, more than the OECD (Organisation for Economic Co-operation and Development) average of $4986 (USD PPP). This is equal to 12.1% of GDP, compared to 9.2% on average in the OECD. 

Market Trend: The French government operates a universal health insurance (SHI) program for all of its citizens. Nearly 95% of people have Voluntary Health Insurance (VHI), with 10.5% receiving means-tested subsidies and 8% receiving full subsidies for those with lower incomes. 

 

France’s medical equipment market is expected to have a revenue of approximately 20.58 billion USD by 2028.

Market Info

Medical Device Regulation

National Agency for the Safety of Medicines and Health Products, under the French National Authority for Health.

https://gnius.esante.gouv.fr/en

Regulation of medical devices to be done with local listing and communicated to France ANSM Registration.

Classification, Fees, Timeline
Regulation
Classification
Product Registration Routes

Class I 

Class IIa, IIb, III, AIMDs 

All Medical Devices need to bear the CE marking in order to be marketed in France. 

Regstration Routes
Useful Information

Validity of License: 5 years 

 

License transfer: Change of Registration application needed.

 

Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.

Quality System: ISO 13485:2016

Useful Info

Besoin de plus de détails ? 

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