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市场信息
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.
医疗器械法规
Spanish Agency of Medicines and Medical Products (AEMPS).
https://www.aemps.gob.es/productos-sanitarios/productos-sanitarios/?lang=en
分类、费用、时间表
产品注册途径
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.
有用信息
许可证有效期：5年
许可证转让：需要申请注册变更。
进口商和分销商：本地许可证持有人代表产品所有者负责指定进口商和分销商。
质量体系：ISO 13485:2016
