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市场信息
瑞士的医疗保健支出是世界上最高的国家之一，人均支出为 8049 美元，远高于经合组织平均水平 4986 美元。
市场趋势：在瑞士，每个公民都必须拥有自己的私人医疗保险，以支付高昂的医疗服务和系统费用。
预计到 2024 年，瑞士医疗设备市场的收入将达到 48.5 亿美元。
分类、费用、时间表
产品注册途径
Class I, IIa, IIb, III, AIMDs
All Medical Devices need to have an appointed European Authorised Representative to export their devices to Europe, and vice versa. The devices have to be in compliance with the Medical Device Ordinance (MedDo). The devices need to be affixed with the Unique Device Identifiers (UDI) according to the timelines,
- from 26 May 2021 for implantable devices and Class III devices
- from 26 May 2023 for Class IIa and IIb devices
- from 26 May 2025 for Class I devices
- 2 years after the dates given letters a-c for the relevant product class for reusable devices
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.
Quality System: ISO 13485:2016
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