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市场信息
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.
医疗器械法规
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.
分类、费用、时间表
产品注册途径
Class I
Class IIa, IIb, III, AIMDs
All Medical Devices need to bear the CE marking in order to be marketed in France.
有用信息
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
