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Bulgaria
市场信息
Bulgaria’s healthcare expenditure is expressed in US dollars per capita, which are inclusive of the current health costs with healthcare products and services that are used annually. There is a trend in the increase of healthcare costs, where in 2020, Bulgaria spent $857 on healthcare, which was an increase of 22.76% over 2019.
Market Trend: The National Health Insurance Fund (NHIF) is the sole purchaser of Bulgaria's social health insurance (SHI) program, which is highly controlled and based on a mandate.
Bulgaria’s medical equipment market is one of the smaller ones in the EU, which will post a mid-single-digit local currency compound annual growth rate (CAGR) over the 2018-2024 timeframe. The market is heavily dependent on imports, the majority of which come from the US and other EU members. For any growth in the market, it will be reliant on the success of initiatives to expand the private sector and increased funding in healthcare.
The Bulgarian association of suppliers and producers of medical devices, MedTech, has leading national and international healthcare companies that are among its members.
医疗器械法规
MedTech Bulgaria
Registration of Medical Devices to be done under
https://www.bda.bg/en/registers/114-information-for-companies-section/medical-devices-category
分类、费用、时间表
产品注册途径
Class I
4-6 weeks after submission
Class IIa, IIb, III
Depends on the contract with the notified body and type of device
有用信息
许可证有效期:5年
许可证转让:需要提交注册变更申请。
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。
适用的质量管理体系:ISO 13485
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