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Volumn 3, Issue 1, 2010, Pages 67-79

Medical device vigilance systems: India, US, UK, and Australia

Author keywords

GHTF; India; Medical device; Regulatory systems; Vigilance

Indexed keywords

BINARY ALLOYS; BIOMEDICAL ENGINEERING; CUTTING EQUIPMENT; DIAGNOSTIC PRODUCTS; LAWS AND LEGISLATION; POTASSIUM ALLOYS; URANIUM ALLOYS;

EID: 78650560027     PISSN: None     EISSN: 11791470     Source Type: Journal    
DOI: 10.2147/MDER.S12396     Document Type: Article
Times cited : (26)

References (45)
  • 1
    • 78650568750 scopus 로고    scopus 로고
    • Information document concerning the defnition of the term "Medical Device", May, Accessed 2009 Oct 14
    • Information document concerning the defnition of the term "Medical Device". 2005 May. http://www.ghtf.org/sg1/sg1-fnal.html. Accessed 2009 Oct 14.
    • (2005)
  • 2
    • 78650553081 scopus 로고    scopus 로고
    • Guidance For Industry and FDA Staff: Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act. Apr, Accessed 2009 Aug 8
    • Guidance for Industry and FDA Staff: postmarket surveillance under section 522 of the Federal Food, Drug and Cosmetic Act. 2006 Apr. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072564.pdf. Accessed 2009 Aug 8.
    • (2006)
  • 4
    • 78650553396 scopus 로고    scopus 로고
    • European Commission Enterprise and Industry: Medical Devices, Cited 2010 Apr 27, Sep 25
    • European Commission Enterprise and Industry: Medical Devices. Cited 2010 Apr 27. http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm. Accessed 2009 Sep 25.
    • (2009)
  • 5
    • 78650577046 scopus 로고
    • Council Directive 93/42/EEC concerning medical devices, Jun. Cited 2009 Sep 5
    • Council Directive 93/42/EEC concerning medical devices. 1993 Jun. Cited 2009 Sep 5. http://ec.europa.eu/enterprise/sectors/medical-devices/documents/revision/index_en.htm
    • (1993)
  • 6
    • 78650537767 scopus 로고    scopus 로고
    • Registration of medical devices, Accessed 2010 Apr 29
    • Registration of medical devices. http://www.mhra.gov.uk/Howweregulate/Devices/Registrationofmedicaldevices/index.htm. Accessed 2010 Apr 29.
  • 7
    • 78650534249 scopus 로고
    • Council Directive on the approximation of laws of the member states relating to active implantable medical devices (90/385/EEC)., Jun 20. Cited 2010 Mar 15
    • Council Directive on the approximation of laws of the member states relating to active implantable medical devices (90/385/EEC). 1990 Jun 20. Cited 2010 Mar 15. http://eurlex.europa.eu/LexUriServ.do?uri=CONSLEG:1990L0385:20071011:en:PDF
    • (1990)
  • 8
    • 78650539081 scopus 로고    scopus 로고
    • About GHTF, Accessed 2009 Oct 12
    • About GHTF. http://www.ghtf.org/about/. Accessed 2009 Oct 12.
  • 9
    • 78650563845 scopus 로고    scopus 로고
    • Directives Bulletin No. 3: guidance on the operation of EU vigilance system in UK, Sep, Accessed 2009 Aug 11
    • Directives Bulletin No. 3: guidance on the operation of EU vigilance system in UK. 2008 Sep. http://www.mhra.gov.uk/Publications/Regulatoryuidance/Devices/DirectivesBulletins/CON2033888. Accessed 2009 Aug 11.
    • (2008)
  • 10
    • 78650537766 scopus 로고    scopus 로고
    • Guidelines for import and manufacture of medical devices, Accessed 2009 Sep 18
    • Guidelines for import and manufacture of medical devices. http://www.cdsco.nic.in/medical%20device%20A42.html. Accessed 2009 Sep 18.
  • 11
    • 78650540881 scopus 로고    scopus 로고
    • Clarifcation with regard to control of various medical devices, Mar, Accessed 2009 Dec 12
    • Clarifcation with regard to control of various medical devices. 2009 Mar. http://www.cdsco.nic.in/MEDICAL%20DEVICE%20page.htm. Accessed 2009 Dec 12.
    • (2009)
  • 12
    • 78650567066 scopus 로고    scopus 로고
    • The Medical Device Regulations Bill, Accessed 2009 Aug 29
    • The Medical Device Regulations Bill, 2006. http://dst.gov.in/whats_new/whats_new07/MDRA-Act.pdf. Accessed 2009 Aug 29.
    • (2006)
  • 13
    • 78650570422 scopus 로고    scopus 로고
    • National Workshop: Medical Device Regulations in India, July 12. New Delhi: FICCI
    • National Workshop: Medical Device Regulations in India; 2010 July 12. New Delhi: FICCI.
    • (2010)
  • 14
    • 78650573095 scopus 로고    scopus 로고
    • Medical devices and equipment, Accessed Cited 2009 Dec 16
    • Medical devices and equipment. http://www.fcci.com/sector-details.asp?secid=76. Accessed Cited 2009 Dec 16.
  • 15
    • 78650529969 scopus 로고    scopus 로고
    • Adverse event reporting. Central Drugs Standard Control Organisation, Accessed 2010 Jul 19
    • Adverse event reporting. Central Drugs Standard Control Organisation. http://CDSCO-AER/Meddevice. Accessed 2010 Jul 19.
  • 16
    • 78650533081 scopus 로고    scopus 로고
    • Principles of medical devices classifcation, June, Accessed 2009 Oct 14
    • Principles of medical devices classifcation. 2006 June. http://www.ghtf.org/GHTF/SG1/N15:2006. Accessed 2009 Oct 14.
    • (2006)
  • 17
    • 78650555275 scopus 로고    scopus 로고
    • Device classifcation, Jul, Accessed 2009 Sep 30
    • Device classifcation. 2009 Jul. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm. Accessed 2009 Sep 30.
    • (2009)
  • 18
    • 78650562845 scopus 로고    scopus 로고
    • Australian Medical Device Guidance Document Number 25: classifcation of medical device, Jan, Accessed 2009 Aug 12
    • Australian Medical Device Guidance Document Number 25: classifcation of medical device. 2005 Jan. http://www.tga.gov.au/docs/pdf/devguid25.pdf. Accessed 2009 Aug 12.
    • (2005)
  • 19
    • 78650525597 scopus 로고    scopus 로고
    • Bulletin No. 10: the classifcation rules, Feb, Accessed 2009 Sep 28
    • Bulletin No. 10: the classifcation rules. 2006 Feb. http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007495.pdf. Accessed 2009 Sep 28.
    • (2006)
  • 20
    • 78650546769 scopus 로고    scopus 로고
    • Medical device tracking, May, Accessed 2009 Aug 8
    • Medical device tracking. 2009 May. http://www.fda.gov/DeviceRegulationandGuidance/PostmarketRequirements/MedicalDeviceTracking/default.htm-32k-2008-10-15. Accessed 2009 Aug 8.
    • (2009)
  • 21
    • 78650557835 scopus 로고    scopus 로고
    • Medical device tracking: guidance for Industry and FDA Staff, Accessed 2009 Aug 8, May
    • Medical device tracking: guidance for Industry and FDA Staff. 2003 May. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071756.htm-67k-2009-01-29. Accessed 2009 Aug 8.
    • (2003)
  • 22
    • 78650575086 scopus 로고    scopus 로고
    • Medical device tracking requirements, Apr, Accessed 2009 Aug 8
    • Medical device tracking requirements. 2008 Apr. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071756.htm-67k-2009-01-29. Accessed 2009 Aug 8.
    • (2008)
  • 23
    • 78650572473 scopus 로고    scopus 로고
    • Inspection of medical device manufacturers: Attachment D: summary of tracking requirement, May., Accessed 2009 Aug 15
    • Inspection of medical device manufacturers: Attachment D: summary of tracking requirements. 2009 May. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm149673.htm. Accessed 2009 Aug 15.
    • (2009)
  • 24
    • 78650541869 scopus 로고    scopus 로고
    • Australian medical device guidelines: postmarket activities, Accessed 2009 Aug 14
    • Australian medical device guidelines: postmarket activities. 2003. http://www.tga.gov.au/pdf/devguid11.pdf. Accessed 2009 Aug 14.
    • (2003)
  • 25
    • 78650550392 scopus 로고    scopus 로고
    • Feb, Accessed 2009 Aug 14
    • Regulation of medical devices. 2009 Feb. http://www.tga.gov.au/devices/devices.htm. Accessed 2009 Aug 14.
    • (2009) Regulation of Medical Devices
  • 26
    • 78650558659 scopus 로고    scopus 로고
    • MDEC Meeting 2005/2. 2005 Jun., Accessed 2009 Aug 16
    • MDEC Meeting 2005/2. 2005 Jun. http://www.tga.gov.au/docs/html/mdec/mdec20052.htm. Accessed 2009 Aug 16.
  • 27
    • 78650573429 scopus 로고    scopus 로고
    • Medical devices post market surveillance: global guidance for adverse event reporting for medical devices, Nov, Accessed 2009 Oct 25
    • Medical devices post market surveillance: global guidance for adverse event reporting for medical devices. 2006 Nov. http://www.ghtf.org/GHTF/SG2/N54R8:2006. Accessed 2009 Oct 25.
    • (2006)
  • 28
    • 78650566127 scopus 로고    scopus 로고
    • Medical device reporting for manufacturers, Mar, Accessed 2009 Aug 10
    • Medical device reporting for manufacturers. 1997 Mar. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094529.htm. Accessed 2009 Aug 10.
    • (1997)
  • 29
    • 78650534571 scopus 로고    scopus 로고
    • Medical device reporting: manufacturer reporting requirements, Apr, Accessed 2009 Aug 10
    • Medical device reporting: manufacturer reporting requirements. 2008 Apr. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance. Accessed 2009 Aug 10.
    • (2008)
  • 30
    • 78650533080 scopus 로고    scopus 로고
    • Reporting adverse events (medical devices), Aug, Accessed 2009 Aug 10
    • Reporting adverse events (medical devices). 2009 Aug. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Postmarket Requirements/ReportingAdverseEvents/default.htm. Accessed 2009 Aug 10.
    • (2009)
  • 32
    • 78650549716 scopus 로고    scopus 로고
    • Australian medical device guidelines: obligations and responsibilities of medical device manufacturers and sponsors, Accessed 2009 Aug 14
    • Australian medical device guidelines: obligations and responsibilities of medical device manufacturers and sponsors. 2003. http://www.tga.gov.au/docs/html/devguid20.htm. Accessed 2009 Aug 14.
    • (2003)
  • 33
    • 78650544336 scopus 로고    scopus 로고
    • Making medical device vigilance more effective, Nov, Accessed 2009 Aug 11
    • Making medical device vigilance more effective. 2007 Nov. http://www.mhra.gov.uk/NewsCentre/CON2033159. Accessed 2009 Aug 11.
    • (2007)
  • 34
    • 78650541214 scopus 로고    scopus 로고
    • New medical devices vigilance guidance system MEDDEV version 5, Accessed 2009 Aug 15
    • New medical devices vigilance guidance system MEDDEV version 5. http://www.mhra.gov.uk/Publications/Regulatoryuidance/Devices/DirectivesBulletins/CON2033888. Accessed 2009 Aug 15.
  • 35
    • 78650556542 scopus 로고    scopus 로고
    • Medical device reporting - remedial action exemption; guidance for FDA and Industry, Sep, Accessed 2009 Aug 15
    • Medical device reporting - remedial action exemption; guidance for FDA and Industry. 2001 Sep. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071354.htm. Accessed 2009 Aug 15.
    • (2001)
  • 37
    • 78650559310 scopus 로고    scopus 로고
    • Medical devices: post market surveillance: National Competent Authority Report Exchange Criteria and Report Form, Feb, Accessed 2009 Oct 8
    • Medical devices: post market surveillance: National Competent Authority Report Exchange Criteria and Report Form. 2009 Feb. http://www.ghtf.org/GHTF/SG2/N79R11:2009. Accessed 2009 Oct 8.
    • (2009)
  • 38
    • 78650565828 scopus 로고    scopus 로고
    • Application requirements for participation in the GHTF National Competent Authority Report Exchange Program, Jul, Accessed 2009 Oct 25
    • Application requirements for participation in the GHTF National Competent Authority Report Exchange Program. 2009 Jul. http://www.ghtf.org/GHTF/SG2/N38R19:2009. Accessed 2009 Oct 25.
    • (2009)
  • 39
    • 78650553082 scopus 로고    scopus 로고
    • Offences/enforcement/illegal supply of medical devices, Oct, Accessed 2009 Aug 16
    • Offences/enforcement/illegal supply of medical devices. 2006 Oct. http://www.tga.gov.au/devices/fs-offences.htm. Accessed 2009 Aug 16.
    • (2006)
  • 40
    • 78650578268 scopus 로고    scopus 로고
    • Suspension and cancellation of a medical device entry in the Australian Register of Therapeutic Goods (ARTG), Oct, Accessed 2009 Aug 16
    • Suspension and cancellation of a medical device entry in the Australian Register of Therapeutic Goods (ARTG). 2006 Oct. http://www.tga.gov.au/devices/fs_suspcanc.htm. Accessed 2009 Aug 16.
    • (2006)
  • 41
    • 78650557834 scopus 로고    scopus 로고
    • Uniform recall procedure for therapeutic goods, Accessed 2009 Aug 16
    • Uniform recall procedure for therapeutic goods. 2004. http://www.tga.gov.au/docs/html.urptg.htm. Accessed 2009 Aug 16.
    • (2004)
  • 42
    • 78650531784 scopus 로고    scopus 로고
    • Recalls, corrections and removals (devices), Jul, Statutory Instrument 2002 No.618: The Medical Device Regulations 2002. 2002 Jun. Cited 2009 Oct 7, Accessed 2009 Sep 30
    • Recalls, corrections and removals (devices). 2009 Jul. Available from: http://www.fda.gov Statutory Instrument 2002 No.618: The Medical Device Regulations 2002. 2002 Jun. Cited 2009 Oct 7. http://www.mhra.gov.uk/. Accessed 2009 Sep 30.
    • (2009)
  • 43
    • 78650551333 scopus 로고    scopus 로고
    • Medical devices post market surveillance: content of feld safety notices, Jun, Accessed 2009 Oct 8
    • Medical devices post market surveillance: content of feld safety notices. 2006 Jun. Available from: http:www.ghtf.org/GHTF/SG2/N57R8:2006. Accessed 2009 Oct 8.
    • (2006)
  • 44
    • 78650571524 scopus 로고    scopus 로고
    • Medical devices post market surveillance: content of feld safety notices, Jun, Accessed 2009 Oct 25
    • Medical devices post market surveillance: content of feld safety notices. 2006 Jun. http://www.ghtf.org/GHTF/SG2/N57R8:2006. Accessed 2009 Oct 25.
    • (2006)
  • 45
    • 78650575085 scopus 로고    scopus 로고
    • Comparison of the Device Adverse Reporting Systems in USA, Europe, Australia, Canada and Japan., May, Accessed 2009 Sep 2
    • Comparison of the Device Adverse Reporting Systems in USA, Europe, Australia, Canada and Japan. 2002 May. http://www.ghtf.org/GHTF/SG2/N6R3:2002. Accessed 2009 Sep 2.
    • (2002)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.