SUBMIT INQUIRY
Bulgaria
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY:
Devices are regulated by the EU list of Competent Authorities. In Bulgaria, devices are regulated by the Bulgarian Drug Agency Department Medical devices (BDA).

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.

TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

LICENSE VALIDITY: Licenses issued in the EU are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.

ADDITIONAL INFORMATION: On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

Additional registration with the Bulgarian Drug Agency, under the Ministry of Health, is required. 

Last updated on October 22, 2018.



Interested in obtaining fast market approval for your medical device or IVD in the EU? REQUEST A FREE QUOTE>

For more information on registration in the EU, check out the following articles on our blog:
5 Questions and Answers: Additional Regulations in the EU
4 Steps to Comply With EU Directive RoHS 2
latest news
  • Oct 3 2018
    REGULATORY UPDATE - LABORIE

    China: Laborie's Aquarius System was approved for sale with LICENSALE.COM®. ...

    Read More
  • Sep 28 2018
    REGULATORY UPDATE - VAREX IMAGING CORP.

    Canada: Varex Imaging's Nexus DR was approved for sale with LICENSALE.COM®....

    Read More
  • Sep 12 2018
    REGULATORY UPDATE - TECHNOPATH CLINICAL DIAGNOSTICS

    Canada: Technopath Clinical Diagnostics' Multichem A1C was approved for sale with LICENSALE.COM®. ...

    Read More
  • Aug 16 2018
    REGULATORY UPDATE - VIASONIX

    Canada: Viasonix' Dolphin family of products was approved for sale with LICENSALE.COM®....

    Read More
  • Aug 8 2018
    REGULATORY UPDATE - ORASURE TECHNOLOGIES

    Nepal: OraSure Technologies' OraQuick HIV Self-Test was approved for sale with LICENSALE.COM®....

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP