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Volumn 196, Issue 4, 2012, Pages 256-260

Medical device regulation in Australia: Safe and effective?

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; AUSTRALIA; DEVICE RECALL; HEALTH CARE DELIVERY; HEALTH CARE MANAGEMENT; HUMAN; INCIDENCE; INJURY; MEDICAL DEVICE; MORTALITY; OUTCOME ASSESSMENT; REGULATORY MECHANISM; RETROSPECTIVE STUDY; RISK FACTOR; SAFETY; THERAPEUTIC GOODS ADMINISTRATION;

EID: 84857843416     PISSN: 0025729X     EISSN: 13265377     Source Type: Journal    
DOI: 10.5694/mja11.11261     Document Type: Article
Times cited : (18)

References (11)
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    • Medical-device recalls in the UK and the device-regulation process: Retrospective review of safety notices and alerts
    • Heneghan C, Thompson M, Billingsley M, Cohen D. Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open 2011; 1: e000155.
    • (2011) BMJ Open , vol.1
    • Heneghan, C.1    Thompson, M.2    Billingsley, M.3    Cohen, D.4
  • 2
    • 79956336424 scopus 로고    scopus 로고
    • Out of joint: The story of the ASR
    • Cohen D. Out of joint: the story of the ASR. BMJ 2011; 342: d2905.
    • (2011) BMJ , vol.342
    • Cohen, D.1
  • 3
    • 79959669735 scopus 로고    scopus 로고
    • What is happening with hip replacement?
    • Graves SE. What is happening with hip replacement? Med J Aust 2011; 194: 1-2.
    • (2011) Med J Aust , vol.194 , pp. 1-2
    • Graves, S.E.1
  • 4
    • 79955726540 scopus 로고    scopus 로고
    • Medical device recalls and the FDA approval process
    • Zuckerman D, Brown P, Nissen S. Medical device recalls and the FDA approval process. Arch Intern Med 2011; 171: 1006-1011.
    • (2011) Arch Intern Med , vol.171 , pp. 1006-1011
    • Zuckerman, D.1    Brown, P.2    Nissen, S.3
  • 5
    • 78650480589 scopus 로고    scopus 로고
    • Australian Government Department of Health and Ageing., December. Canberra: DoHA, 2009. (accessed Jan 2012)
    • Australian Government Department of Health and Ageing. Review of health technology assessment in Australia, December 2009. Canberra: DoHA, 2009. http://www.health. gov.au/internet/main/publishing.nsf/Content/ 00E847C9D69395B9CA25768F007F589A/ $File/hta-review-report.pdf (accessed Jan 2012).
    • (2009) Review of health technology assessment in Australia
  • 6
    • 84857863525 scopus 로고    scopus 로고
    • Therapeutic Goods Administration. Proposals. Canberra: TGA, (accessed Jan 2012)
    • Therapeutic Goods Administration. Reforms to the medical devices regulatory framework. Proposals. Canberra: TGA, 2011. http:// www.tga.gov.au/newsroom/consult-devicesreforms-110923.htm (accessed Jan 2012).
    • (2011) Reforms to the medical devices regulatory framework
  • 7
    • 84857843340 scopus 로고    scopus 로고
    • Review to improve the transparency of the Therapeutic Goods Administration
    • Panel to Review the Transparency of the Therapeutic Goods Administration., June, Canberra: Commonwealth of Australia, 2011. (accessed Jan 2012)
    • Panel to Review the Transparency of the Therapeutic Goods Administration. Review to improve the transparency of the Therapeutic Goods Administration. Final report, June 2011. Canberra: Commonwealth of Australia, 2011. http://www.tga.gov.au/newsroom/review-tgatransparency-1101.htm (accessed Jan 2012).
    • (2011) Final report
  • 8
    • 84857876157 scopus 로고    scopus 로고
    • Senate Standing Committees on Community Affairs
    • Canberra: Parliament of Australia Senate, (accessed Feb 2012)
    • Senate Standing Committees on Community Affairs. Inquiry into the regulatory standards for the approval of medical devices. Canberra: Parliament of Australia Senate, 2011. http:// www.aph.gov.au/Parliamentary_Business/ Committees/Senate_Committees?url=clac_ctte/ medical_devices/report/index.htm (accessed Feb 2012).
    • (2011) Inquiry into the regulatory standards for the approval of medical devices
  • 9
    • 84857819586 scopus 로고    scopus 로고
    • Therapeutic Goods Administration. Canberra: TGA, (accessed Jan 2012)
    • Therapeutic Goods Administration. TGA reforms: a blueprint for TGA's future. Canberra: TGA, 2011. http://www.tga.gov.au/newsroom/media-2011-tga-reforms-111208.htm (accessed Jan 2012).
    • (2011) TGA reforms: A blueprint for TGA's future
  • 10
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    • Australian Government Department of Health and Ageing Therapeutic Goods Administration. Canberra: TGA, (accessed Jan 2012)
    • Australian Government Department of Health and Ageing Therapeutic Goods Administration. Australian regulatory guidelines for medical devices (ARGMD). Canberra: TGA, 2011. http:// www.tga.gov.au/industry/devices-argmd.htm (accessed Jan 2012).
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  • 11
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    • 1989 (Cwlth) (as amended) (accessed Jan 2012)
    • Therapeutic Goods Act 1989 (Cwlth) (as amended). http://www.comlaw.gov.au/Details/ C2011C00589/Html/Text#_Toc299972112 (accessed Jan 2012).
    • Therapeutic Goods Act


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.