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市场信息
EU's healthcare expenditure has increased by 24.1% from 2012 to 2020
Market Trend: In EU, there has been a steady increase in the total expenditure of healthcare as technology advances and more investment is made into the quality of healthcare provided.
EU’s medical equipment market is projected to reach US$143.20 billion in 2024.
Medical Device Regulation
European Union Medical Device Regulation
https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices
分类、费用、时间表
产品注册途径
Class I, IIa, IIb, III, AIMDs
All Medical Devices needs to be affixed with the Conformité Européenne (CE) mark in order to be marketed. The new rules and regulations are applied since 26 May 2021. All manufacturers need to comply with the regulations before placing the medical devices on the market.
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.
