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Market Information
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.
Medical Device Regulation
MedTech Bulgaria
Registration of Medical Devices to be done under
https://www.bda.bg/en/registers/114-information-for-companies-section/medical-devices-category
Classification, Fees, Timeline
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Product Registration Routes
Class I
4-6 weeks after submission
Class IIa, IIb, III
Depends on the contract with the notified body and type of device
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.
Applicable QMS: ISO 13485
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