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Market Information
Spain's healthcare expenditure has been linearly increasing with the most recent recorded value of 2,926 USD per capita in 2021.
Market Trend: In Spain, the healthcare is funded by from a combination of taxes and social security contributions, with the autonomous regions being accountable for managing and allocating healthcare funds provided by the central government.
Spain’s medical equipment market is estimated to reach 10.90 billion USD by 2028.
Medical Device Regulation
Spanish Agency of Medicines and Medical Products (AEMPS).
https://www.aemps.gob.es/productos-sanitarios/productos-sanitarios/?lang=en
Classification, Fees, Timeline
Product Registration Routes
Class I
Can be placed on market immediately with the CE marking
Class IIa, IIb, III, AIMDs
Requires a submission of communication to the Regulatory Authority
All Medical Devices need to bear the CE marking in order to be marketed in Spain.
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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