Obelis Launches a Bulgarian National Registration Service

In accordance with the Law on Medical Devices, adopted by the  Bulgarian Parliament during its session on June 12, 2007, and as  promulgated in the Bulgarian State Gazette No. 46, some categories of medical devices must be registered with the Bulgarian Drug Agency (BDA). This  registration is mandatory for medical devices that enter the EU internal  market through, or if they are being manufactured in, the territory of  Bulgaria.

The categories of medical devices that are affected by this obligatory registration are:

• Class I Medical Devices;
• Class Is and Class I Medical Devices;
• Custom-made Medical Devices;
• Systems and procedure packs;
• Systems and procedure packs subjected to sterilization before use;
• Medical Devices subjected to sterilization before use;
• In Vitro Diagnostic Devices

The manufacturers of Medical Devices that are classes IIa IIb and  III, and established outside Bulgaria, are exempted from this  requirement.

Obelis, as a professional European Authorized Representative,  can perform the registration procedure on behalf of Non-EU  manufacturers. A registration application form is provided by BDA and  the file is submitted as a hard copy via post or courier.

For more information, you can visit the following links:

With more than 25 years of experience within the Medical Devices  field, the Obelis team is available to answer any questions you may have  about European directives and CE Marking, and to guide you through the  Bulgarian national registration procedure.

If you want to start selling your devices on the European market,  through Bulgaria, and you require more information, please do not  hesitate to contact us!

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