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Medical devices

Medical devices

Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices

Medical Devices categories

Application for the registration of manufacturers and In Vitro Diagnostic Medical Devices placed on the market and/or putting into service in Bulgaria, in accordance with Art.28(1) and (3) of MDL / IVDMD Directive, Art.10

Application for the registration of manufacturers and medical devices, placed on the Bulgarian market and/or putting into service, in accordance with art. 27 (1) of MDL

Form to submit an information for medical devices putting into service in Bulgaria, in accordance with art. 30 of MDL

Form for the notification of In Vitro Diagnostic Medical Devices IVDMD Directive, Art.10.6

Medical devices

Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices

Template of Declaration of conformity contents (There are no translations available)

Important links about medical device regulation:

  • European Commission - Medical Device Sector:

http://ec.europa.eu/enterprise/medical_devices/index_en.htm

  • Guidelines relating to Medical Device Directives:

http://ec.europa.eu/consumers/sectors/medical_devices/documents/guidelines/index_en.htm

  • Global Harmonization in Medical Device Regulation. Guidelines:

http://www.ghtf.org/whatsnew.html

  • Medical Device Nomenclature Systems:

http://www.ecri.org/Products/Pages/UMDNS.aspx

http://www.gmdnagency.com/?id=nom

Medical devices

Information for applicants regarding email created for contact, information and documents submission about clinical investigation and performance studies

As of 19.01.2026 applications/notifications and accompanying documentation for conducting clinical investigations with medical devices and performance studies with in vitro diagnostic medical devices on the territory of the Republic of Bulgaria, as well as for substantial modifications in the studies can also be submitted electronically to the following email address: This email address is being protected from spambots. You need JavaScript enabled to view it..

The customary way for submitting of applications/notifications and accompanying documentation for conducting clinical investigations with medical devices and performance studies with in vitro diagnostic medical devices on the territory of the Republic of Bulgaria, as well as for substantial modifications in the studies, remains in force - on paper and/or electronic carrier in chancery of BDA , in person or by courier (mail) by a sponsor’s investigation authorized representative on the following address: Bulgaria, Sofia 1303, 8 Damyan Gruev str., BULGARIAN DRUG AGENCY.