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Market Information
Italy’s healthcare expenditure has increased steadily over the years, with spendings of approximately $4291 per capita on health in 2023, which is less than the OECD (Organisation for Economic Co-operation and Development) average of $4986 (USD PPP). This is equal to 9.0% of GDP, compared to 9.2% on average in the OECD.
Market Trend: The Italian government provides low to cost-free healthcare for its residents, with public health insurance provided.
Italy’s medical equipment market is expected to have a revenue of approximately 14.91 billion USD by 2028.
Medical Device Regulation
National Database of Medical Devices in accordance with the Ministry of Health
Classification, Fees, Timeline
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 Italy.
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
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