0A4F4F9BD490A749D5437F821CF06DF1

Various Guidelines on Drugs, Biologics, and Devices

https://www.bda.bg/en/114-information-for-companies-section/medical-devices-category

http://leaux.net/URLS/ConvertAPI Text Files/A67FDE5B0EF2115A3F39FFC6D66920CA.en.txt

Examining the file media/Synopses/A67FDE5B0EF2115A3F39FFC6D66920CA.html:

This file was generated: 2020-07-14 08:00:16

Indicators in focus are typically shown highlighted in yellow; Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; "Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
HealthDrug Usagedrug3
SocialProperty Ownershiphome1
General/OtherRelationship to Authorityauthority1

Health / Drug Usage

Searching for indicator drug:

(return to top)
p.000008:   Site 
p.000008: Search map …
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Search... 
p.000008:
p.000008:
p.000008: »»»| 
p.000008:
p.000008: FOR CITIZENS
p.000008:
p.000008: - Choose menu item -
p.000008:
p.000008: FOR COMPANIES
p.000008:
p.000008: - Choose category -
p.000008:
p.000008: FOR MEDICAL SPECIALISTS
p.000008:
p.000008: - Choose menu item -
p.000008:
p.000008:
p.000008: Medical devices
p.000008:
p.000008:   Medical devices  30 may 2011
p.000008: Instructions to the submitters for preparation of a list of medical
p.000008: devices
p.000008:
p.000008:
p.000008:
p.000008: Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application
p.000008: form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices 8
p.000008:
p.000008:
p.000008: Template of Declaration of conformity contents (There are no translations available)
p.000008:
p.000008:
p.000008:  Important links about medical device regulation:
p.000008:
p.000008: European Commission - Medical Device Sector:
p.000008:
p.000008: & http://ec.europa.eu/enterprise/medical_devices/index_en.htm
p.000008:
p.000008: Guidelines relating to Medical Device Directives:
p.000008:
p.000008: & http://ec.europa.eu/consumers/sectors/medical_devices/documents/guidelines/index_en.htm
p.000008:
p.000008: Global Harmonization in Medical Device Regulation. Guidelines:
p.000008:
p.000008: & http://www.ghtf.org/whatsnew.html
p.000008:
p.000008: Medical Device Nomenclature Systems:
p.000008:
p.000008: & http://www.ecri.org/Products/Pages/UMDNS.aspx
p.000008:
p.000008: & http://www.gmdnagency.com/?id=nom
p.000008:
p.000008:
p.000008:   Medical devices  30 may 2011
p.000008: Guidelines
p.000008:
p.000008:
p.000008: (There are no translations available)
p.000008: 8
p.000008:
p.000008:
p.000008:   Medical devices  30 may 2011
p.000008: Vigilance system
p.000008:
p.000008:
p.000008:
p.000008: Guidelines on Medical Devices Vigilance System (There are no translations available)
p.000008: 8
p.000008: Template for a Field Safety Notice
p.000008:
p.000008: Template for National Competent Authority Report (There are no translations available)
p.000008:
p.000008: Report Form Manufacturer's Incident Report (initial/final incident report)
p.000008:
p.000008: Report Form Field Safety Corrective Action
p.000008:
p.000008: Incidents/ potential incidents Report Form for medical devices, in accordance with art.104 of MDL
p.000008:
p.000008:
p.000008:
p.000008:   Medical devices  30 may 2011
p.000008: Clinical trials
p.000008:
p.000008:
p.000008:
p.000008: Notes on completing the Clinical Investigation Notification / Application Form
p.000008: 8
p.000008: Application form for Statement of Ethics Committee for Clinical Investigation of Medical Device
p.000008:
p.000008: Application form to Ethics Committee for Signi cant Changes in Clinical Investigation of Medical Device and Documentation on art. 48 (1) of
p.000008: MDL
p.000008:
p.000008: Notification form for Medical Device Clinical Investigation (art. 45 (2) of MDL)
p.000008:
p.000008: Clinical Investigation Application form art. 45 (1) of MDL
p.000008:
p.000008: Application form to BDA for significant changes in clinical Investigation and documentation on art. 50 (1) of MDL
p.000008:
p.000008: Report form for incident/near incident in conduct of clinical investigation of medical device
p.000008:
p.000008: SAE reporting form (MEDDEV 2.7/3)
p.000008:
p.000008:
p.000008:
p.000008:   Medical devices  30 may 2011
p.000008: Forms
p.000008:
p.000008:
p.000008: Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application
p.000008: form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices 8
p.000008:
p.000008:
p.000008: Medical Devices categories
p.000008:
p.000008: Application for the registration of manufacturers and In Vitro Diagnostic Medical Devices placed on the market and/or putting into service in
p.000008: Bulgaria, in accordance with Art.28(1) and (3) of MDL / IVDMD Directive, Art.10
p.000008:
p.000008: Application for the registration of manufacturers and medical devices, placed on the Bulgarian market and/or putting into service, in
p.000008: accordance with art. 27 (1) of MDL
p.000008:
p.000008: Form to submit an information for medical devices putting into service in Bulgaria, in accordance with art. 30 of MDL
p.000008:
p.000008: Form for the notification of In Vitro Diagnostic Medical Devices IVDMD Directive, Art.10.6
p.000008:
p.000008:
p.000008:
p.000008: Important!
p.000008:
p.000008:
p.000008:
p.000008: Administrative information
p.000008: Over-the-Counter Drugs (OTC)
p.000008:
p.000008:
p.000008:
p.000008: List of medicinal products under additional monitoring
p.000008:
p.000008:
p.000008:
p.000008: EMA: Medicines under additional monitoring
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: You are here: Home / Information for companies / Medical devices
p.000008:
p.000008: Copyright © 2017 Bulgarian Drug Agency.  +359 2 8903555  Fax: +359 2 8903434  bda@bda.bg  09:00 - 17:30
p.000008: All Rights Reserved.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: SSL Certificates
...

Social / Property Ownership

Searching for indicator home:

(return to top)
p.000008:
p.000008: Report form for incident/near incident in conduct of clinical investigation of medical device
p.000008:
p.000008: SAE reporting form (MEDDEV 2.7/3)
p.000008:
p.000008:
p.000008:
p.000008:   Medical devices  30 may 2011
p.000008: Forms
p.000008:
p.000008:
p.000008: Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application
p.000008: form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices 8
p.000008:
p.000008:
p.000008: Medical Devices categories
p.000008:
p.000008: Application for the registration of manufacturers and In Vitro Diagnostic Medical Devices placed on the market and/or putting into service in
p.000008: Bulgaria, in accordance with Art.28(1) and (3) of MDL / IVDMD Directive, Art.10
p.000008:
p.000008: Application for the registration of manufacturers and medical devices, placed on the Bulgarian market and/or putting into service, in
p.000008: accordance with art. 27 (1) of MDL
p.000008:
p.000008: Form to submit an information for medical devices putting into service in Bulgaria, in accordance with art. 30 of MDL
p.000008:
p.000008: Form for the notification of In Vitro Diagnostic Medical Devices IVDMD Directive, Art.10.6
p.000008:
p.000008:
p.000008:
p.000008: Important!
p.000008:
p.000008:
p.000008:
p.000008: Administrative information
p.000008: Over-the-Counter Drugs (OTC)
p.000008:
p.000008:
p.000008:
p.000008: List of medicinal products under additional monitoring
p.000008:
p.000008:
p.000008:
p.000008: EMA: Medicines under additional monitoring
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: You are here: Home / Information for companies / Medical devices
p.000008:
p.000008: Copyright © 2017 Bulgarian Drug Agency.  +359 2 8903555  Fax: +359 2 8903434  bda@bda.bg  09:00 - 17:30
p.000008: All Rights Reserved.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: SSL Certificates
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.000008: Instructions to the submitters for preparation of a list of medical
p.000008: devices
p.000008:
p.000008:
p.000008:
p.000008: Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application
p.000008: form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices 8
p.000008:
p.000008:
p.000008: Template of Declaration of conformity contents (There are no translations available)
p.000008:
p.000008:
p.000008:  Important links about medical device regulation:
p.000008:
p.000008: European Commission - Medical Device Sector:
p.000008:
p.000008: & http://ec.europa.eu/enterprise/medical_devices/index_en.htm
p.000008:
p.000008: Guidelines relating to Medical Device Directives:
p.000008:
p.000008: & http://ec.europa.eu/consumers/sectors/medical_devices/documents/guidelines/index_en.htm
p.000008:
p.000008: Global Harmonization in Medical Device Regulation. Guidelines:
p.000008:
p.000008: & http://www.ghtf.org/whatsnew.html
p.000008:
p.000008: Medical Device Nomenclature Systems:
p.000008:
p.000008: & http://www.ecri.org/Products/Pages/UMDNS.aspx
p.000008:
p.000008: & http://www.gmdnagency.com/?id=nom
p.000008:
p.000008:
p.000008:   Medical devices  30 may 2011
p.000008: Guidelines
p.000008:
p.000008:
p.000008: (There are no translations available)
p.000008: 8
p.000008:
p.000008:
p.000008:   Medical devices  30 may 2011
p.000008: Vigilance system
p.000008:
p.000008:
p.000008:
p.000008: Guidelines on Medical Devices Vigilance System (There are no translations available)
p.000008: 8
p.000008: Template for a Field Safety Notice
p.000008:
p.000008: Template for National Competent Authority Report (There are no translations available)
p.000008:
p.000008: Report Form Manufacturer's Incident Report (initial/final incident report)
p.000008:
p.000008: Report Form Field Safety Corrective Action
p.000008:
p.000008: Incidents/ potential incidents Report Form for medical devices, in accordance with art.104 of MDL
p.000008:
p.000008:
p.000008:
p.000008:   Medical devices  30 may 2011
p.000008: Clinical trials
p.000008:
p.000008:
p.000008:
p.000008: Notes on completing the Clinical Investigation Notification / Application Form
p.000008: 8
p.000008: Application form for Statement of Ethics Committee for Clinical Investigation of Medical Device
p.000008:
p.000008: Application form to Ethics Committee for Signi cant Changes in Clinical Investigation of Medical Device and Documentation on art. 48 (1) of
p.000008: MDL
p.000008:
p.000008: Notification form for Medical Device Clinical Investigation (art. 45 (2) of MDL)
p.000008:
p.000008: Clinical Investigation Application form art. 45 (1) of MDL
p.000008:
p.000008: Application form to BDA for significant changes in clinical Investigation and documentation on art. 50 (1) of MDL
p.000008:
p.000008: Report form for incident/near incident in conduct of clinical investigation of medical device
p.000008:
p.000008: SAE reporting form (MEDDEV 2.7/3)
p.000008:
p.000008:
p.000008:
p.000008:   Medical devices  30 may 2011
p.000008: Forms
p.000008:
p.000008:
p.000008: Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application
...

Orphaned Trigger Words


Appendix

Indicator List

IndicatorVulnerability
authorityRelationship to Authority
drugDrug Usage
homeProperty Ownership

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers

Trigger Words

ethics

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
HealthDrug Usagedrug3
SocialProperty Ownershiphome1
General/OtherRelationship to Authorityauthority1