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 Im 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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