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Medical devices

            Medical devices      30 may 2011
            Instructions to the submitters for preparation of a list of 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           8


      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      30 may 2011
            Guidelines


  (There are no translations available)
                                                                                                                                          8


            Medical devices      30 may 2011
          Vigilance system



    Guidelines on Medical Devices Vigilance System (There are no translations available)
                                                                                                                                          8
    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        30 may 2011
          Clinical trials



    Notes on completing the Clinical Investigation Notification / Application Form
                                                                                                                                          8
    Application form for Statement of Ethics Committee for Clinical Investigation of Medical Device

    Application form to Ethics Committee for Signi cant 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        30 may 2011
          Forms


    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             8


    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



           Important!



           Administrative information
                   Over-the-Counter Drugs (OTC)



                   List of medicinal products under additional monitoring



                                                                                                                   EMA: Medicines under additional monitoring




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