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EUROPE

ITALY

ITALY

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Global   >   Europe    
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.

Market Info

Medical Device Regulation

Med Dev Reglulation
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. 

Classification
Registration
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

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