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BulgariaBurgas: Miscellaneous medical devices and products 2022/S 218623713 Contract notice Supplies Legal Basis: Directive 2014/24/EU Section I: Contracting authority I.1)Name and addresses Official name: UNIVERSITETSKA MNOGOPROFILNA BOLNITSA ZA AKTIVNO LEChENIE BURGAS AD National registration number: 102274111 Postal address: ul.STEFAN STAMBOLOV No..73 Town: gr.Burgas NUTS code:BG341 Burgas / Burgas Postal code: 8000 Country: Bulgaria Contact person: IRENA DONCHEVA NIKOLOVAPETKOVA Email:i
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01
Obtain the relevant application forms for Bulgaria-Burgas miscellaneous medical devices from the appropriate regulatory authority.
02
Carefully read the instructions provided with the application forms to understand the requirements.
03
Gather all necessary documentation, including product specifications, safety test results, and any certifications.
04
Complete the application forms accurately, ensuring all information is up-to-date and corresponds with the gathered documentation.
05
Submit the completed application along with the supporting documents to the designated regulatory body in Bulgaria-Burgas.
06
Pay any required fees associated with the application process.
07
Await confirmation and any potential follow-up queries from the regulatory authority regarding your application.

Who needs bulgaria-burgas miscellaneous medical devices?

01
Healthcare professionals in Bulgaria who require specialized medical devices.
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Patients in need of specific medical devices for personal use or treatment.

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Bulgaria-Burgas miscellaneous medical devices refer to various healthcare products that do not fall under standard classifications but are subject to regulatory oversight in the Burgas region of Bulgaria.
Manufacturers, importers, and distributors of miscellaneous medical devices in the Burgas region are required to file relevant documentation with local health authorities.
Filing requires completing specific forms provided by health authorities, providing details about the device, its intended use, manufacturing processes, and compliance with safety standards.
The purpose is to ensure the safety, efficacy, and quality of medical devices that do not fit into established categories, thereby protecting public health.
Information to be reported includes device specifications, manufacturer details, intended use, safety and performance data, and any relevant clinical investigation outcomes.
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