17
CHAPTER 1:
Medical Devices: A History
66. Gov.uk. How government works. Accessed 24 March 2025. https://
www.gov.uk/government/how-government-works
67. UK Parliament. Key Dates in Parliament and Europe. Accessed 24
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evolutionofparliament/legislativescrutiny/parliament-and-europe/
key-dates/
68. Jefferys DB. The regulation of medical devices and the role of the
Medical Devices Agency. Br J Clin Pharmacol. Published online 20
December 2001. Accessed 24 March 2025. https://doi.org/10.1046/
j.0306-5251.2001.01416.x
69. Medicines and Healthcare products Regulatory Agency. Regulating
medical devices in the UK: What you need to do to place a medical
device on the Great Britain, Northern Ireland and European Union
(EU) markets. Updated 17 February 2025. Accessed 24 March 2025.
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
70. Medicines and Healthcare products Regulatory Agency. List of UK
approved bodies for medical devices (guidance). Updated 19 February
2025. Accessed 24 March 2025. https://www.gov.uk/government/
publications/medical-devices-uk-approved-bodies/uk-approved-
bodies-for-medical-devices#contents
71. National Medical Products Administration [China]. Regulations on
Supervision and Management of Medical Devices. Updated 31 May
2021. Accessed 24 March 2025. https://english.nmpa.gov.cn/2021-
05/31/c_644306.htm
72. [In Chinese] Chang YH. The International Origins and Development
of Modern Medical Device Regulation in China. China Food and
Drug Administration Magazine. 2023 (02):16. Published 25 February
2023. Accessed 24 March 2025. http://www.cfdam-health.com/CN/
Y2023/V0/I2/16
73. [In Chinese] National Medical Products Administration [China].
Annual Report on Medical Device Registration for the Year 2023.
Published 5 February 2024. Accessed 1 March 2024. https://www.
nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20240205112550112.html
74. Britannica. Brazil, Government. Accessed 24 March 2025. https://
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75. Underwriters Laboratories (UL). INMETRO Certification
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https://www.ul.com/services/inmetro-certification-requirements-
medical-devices
76. National Health Surveillance Agency (ANVISA). Home. Accessed 24
March 2025. https://www.gov.br/anvisa/pt-br/english
77. National Health Regulatory Agency (ANVISA). Resolution of
the Collegiate Board of Directors RDC No. 185, of October 22nd,
2001. Accessed 24 March 2025. https://anvisalegis.datalegis.net/
action/UrlPublicasAction.php?acao=abrirAtoPublico&num_
ato=00000185&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/
MS&vlr_ano=2001&seq_ato=000&cod_modulo=310&cod_menu=9434
78. National Health Surveillance Agency (ANVISA). Resolution
of the Collegiate Board of Directors RDC 16/2013 -GMP
Requirements for Medical Devices and IVD. Accessed 24 March
2025. https://anvisalegis.datalegis.net/action/UrlPublicasAction.
php?acao=abrirAtoPublico&num_ato=00000016&sgl_
tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_
ano=2013&seq_ato=000&cod_modulo=310&cod_menu=9434
79. National Health Surveillance Agency (ANVISA). Resolution
of the Collegiate Board of Directors RDC 36/2015 -Product
Registration. Accessed 24 March 2025. https://anvisalegis.datalegis.
net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_
ato=00000036&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/
MS&vlr_ano=2015&seq_ato=000&cod_modulo=310&cod_
menu=9434
80. National Health Surveillance Agency (ANVISA). Resolution
of the Collegiate Board RDC No. 751, of 15 September 2022.
Accessed 24 March 2025. https://anvisalegis.datalegis.net/
action/UrlPublicasAction.php?acao=abrirAtoPublico&num_
ato=00000751&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/
MS&vlr_ano=2022&seq_ato=000&cod_modulo=310&cod_
menu=9434
81. McEwen J. A History of Therapeutic Goods Regulation in Australia.
Commonwealth of Australia 2007. Verified 24 March 2025.
82. Therapeutic Goods Act 1989. Federal Register of Legislation. Updated
21 March 2025. Accessed 24 March 2025. https://www.legislation.gov.
au/C2004A03952/latest/versions
83. Therapeutic Goods Administration (TGA). Home. Accessed 24
March 2025. https://www.tga.gov.au/
84. Therapeutic Goods (Medical Devices) Regulations 2002. Federal
Register of Legislation. Updated 14 December 2024. Accessed 24
March 2025. https://www.legislation.gov.au/F2002B00237/latest/text
85. Therapeutic Goods Administration. Therapeutic Goods (Medical
Devices) Regulations 2002 (guidance). Updated 6 March 2025.
Accessed 24 March 2025. https://www.tga.gov.au/resources/legislation/
therapeutic-goods-medical-devices-regulations-2002
86. Therapeutic Goods Amendment (2010 Measures No. 1) Act
2010. Federal Register of Legislation. Updated 15 December
2010. Accessed 24 March 2025. https://www.legislation.gov.au/
C2010A00141/latest/text
87. Therapeutic Goods Administration. Therapeutic Goods Legislation
Amendment (2023 Measures No. 2) Regulations 2023. Accessed
24 March 2025. https://www.tga.gov.au/about-tga/legislation/
legislation-and-legislative-instruments/therapeutic-goods-legislation-
amendment-2023-measures-no-2-regulations-2023
88. Therapeutic Goods Administration. Medical Device Single Audit
Program (MDSAP). Last updated 1 December 2023. Accessed
24 March 2025. https://www.tga.gov.au/how-we-regulate/
manufacturing/manufacture-medical-device/medical-device-single-
audit-program-mdsap
CHAPTER 1:
Medical Devices: A History
66. Gov.uk. How government works. Accessed 24 March 2025. https://
www.gov.uk/government/how-government-works
67. UK Parliament. Key Dates in Parliament and Europe. Accessed 24
March 2025. https://www.parliament.uk/about/living- heritage/
evolutionofparliament/legislativescrutiny/parliament-and-europe/
key-dates/
68. Jefferys DB. The regulation of medical devices and the role of the
Medical Devices Agency. Br J Clin Pharmacol. Published online 20
December 2001. Accessed 24 March 2025. https://doi.org/10.1046/
j.0306-5251.2001.01416.x
69. Medicines and Healthcare products Regulatory Agency. Regulating
medical devices in the UK: What you need to do to place a medical
device on the Great Britain, Northern Ireland and European Union
(EU) markets. Updated 17 February 2025. Accessed 24 March 2025.
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
70. Medicines and Healthcare products Regulatory Agency. List of UK
approved bodies for medical devices (guidance). Updated 19 February
2025. Accessed 24 March 2025. https://www.gov.uk/government/
publications/medical-devices-uk-approved-bodies/uk-approved-
bodies-for-medical-devices#contents
71. National Medical Products Administration [China]. Regulations on
Supervision and Management of Medical Devices. Updated 31 May
2021. Accessed 24 March 2025. https://english.nmpa.gov.cn/2021-
05/31/c_644306.htm
72. [In Chinese] Chang YH. The International Origins and Development
of Modern Medical Device Regulation in China. China Food and
Drug Administration Magazine. 2023 (02):16. Published 25 February
2023. Accessed 24 March 2025. http://www.cfdam-health.com/CN/
Y2023/V0/I2/16
73. [In Chinese] National Medical Products Administration [China].
Annual Report on Medical Device Registration for the Year 2023.
Published 5 February 2024. Accessed 1 March 2024. https://www.
nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20240205112550112.html
74. Britannica. Brazil, Government. Accessed 24 March 2025. https://
www.britannica.com/place/Brazil/Shipping#ref222818
75. Underwriters Laboratories (UL). INMETRO Certification
Requirements for Medical Devices. Accessed 24 March 2025.
https://www.ul.com/services/inmetro-certification-requirements-
medical-devices
76. National Health Surveillance Agency (ANVISA). Home. Accessed 24
March 2025. https://www.gov.br/anvisa/pt-br/english
77. National Health Regulatory Agency (ANVISA). Resolution of
the Collegiate Board of Directors RDC No. 185, of October 22nd,
2001. Accessed 24 March 2025. https://anvisalegis.datalegis.net/
action/UrlPublicasAction.php?acao=abrirAtoPublico&num_
ato=00000185&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/
MS&vlr_ano=2001&seq_ato=000&cod_modulo=310&cod_menu=9434
78. National Health Surveillance Agency (ANVISA). Resolution
of the Collegiate Board of Directors RDC 16/2013 -GMP
Requirements for Medical Devices and IVD. Accessed 24 March
2025. https://anvisalegis.datalegis.net/action/UrlPublicasAction.
php?acao=abrirAtoPublico&num_ato=00000016&sgl_
tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_
ano=2013&seq_ato=000&cod_modulo=310&cod_menu=9434
79. National Health Surveillance Agency (ANVISA). Resolution
of the Collegiate Board of Directors RDC 36/2015 -Product
Registration. Accessed 24 March 2025. https://anvisalegis.datalegis.
net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_
ato=00000036&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/
MS&vlr_ano=2015&seq_ato=000&cod_modulo=310&cod_
menu=9434
80. National Health Surveillance Agency (ANVISA). Resolution
of the Collegiate Board RDC No. 751, of 15 September 2022.
Accessed 24 March 2025. https://anvisalegis.datalegis.net/
action/UrlPublicasAction.php?acao=abrirAtoPublico&num_
ato=00000751&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/
MS&vlr_ano=2022&seq_ato=000&cod_modulo=310&cod_
menu=9434
81. McEwen J. A History of Therapeutic Goods Regulation in Australia.
Commonwealth of Australia 2007. Verified 24 March 2025.
82. Therapeutic Goods Act 1989. Federal Register of Legislation. Updated
21 March 2025. Accessed 24 March 2025. https://www.legislation.gov.
au/C2004A03952/latest/versions
83. Therapeutic Goods Administration (TGA). Home. Accessed 24
March 2025. https://www.tga.gov.au/
84. Therapeutic Goods (Medical Devices) Regulations 2002. Federal
Register of Legislation. Updated 14 December 2024. Accessed 24
March 2025. https://www.legislation.gov.au/F2002B00237/latest/text
85. Therapeutic Goods Administration. Therapeutic Goods (Medical
Devices) Regulations 2002 (guidance). Updated 6 March 2025.
Accessed 24 March 2025. https://www.tga.gov.au/resources/legislation/
therapeutic-goods-medical-devices-regulations-2002
86. Therapeutic Goods Amendment (2010 Measures No. 1) Act
2010. Federal Register of Legislation. Updated 15 December
2010. Accessed 24 March 2025. https://www.legislation.gov.au/
C2010A00141/latest/text
87. Therapeutic Goods Administration. Therapeutic Goods Legislation
Amendment (2023 Measures No. 2) Regulations 2023. Accessed
24 March 2025. https://www.tga.gov.au/about-tga/legislation/
legislation-and-legislative-instruments/therapeutic-goods-legislation-
amendment-2023-measures-no-2-regulations-2023
88. Therapeutic Goods Administration. Medical Device Single Audit
Program (MDSAP). Last updated 1 December 2023. Accessed
24 March 2025. https://www.tga.gov.au/how-we-regulate/
manufacturing/manufacture-medical-device/medical-device-single-
audit-program-mdsap