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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

Guidelines on Medical Devices Vigilance System / There are no translations available

Template for a Field Safety Notice

Template for National Competent Authority Report / There are no translations available

Report Form Manufacturer's Incident Report (initial/final incident report)

Report Form Field Safety Corrective Action

Incidents/ potential incidents Report Form for medical devices, in accordance with art.104 of MDL

 
Medical devices

There are no translations available

 
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)

 
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