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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

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

Notes on completing the Clinical Investigation Notification / Application Form

Application form for Statement of Ethics Committee for Clinical Investigation of Medical Device

Application form to Ethics Committee for Significant Changes in Clinical Investigation of Medical Device and Documentation on art. 48 (1) of MDL

Notification form for Medical Device Clinical Investigation (art. 45 (2) of MDL)

Clinical Investigation Application form art. 45 (1) of MDL

Application form to BDA for significant changes in clinical Investigation and documentation on art. 50 (1) of MDL

Report form for incident/near incident in conduct of clinical investigation of medical device

SAE reporting form (MEDDEV 2.7/3)

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