-
1
-
-
78650568750
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
About GHTF, Accessed 2009 Oct 12
-
About GHTF. http://www.ghtf.org/about/. Accessed 2009 Oct 12.
-
-
-
-
9
-
-
78650563845
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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)
-
-
|