13
CHAPTER 1:
Medical Devices: A History
Agência Nacional de Vigilância Sanitária (ANVISA)
The Brazilian Health Regulatory Agency, commonly known
as ANVISA (Agência Nacional de Vigilância Sanitária), was
established in 1999 and operates under the Ministry of Health.76
ANVISA is characterized by its administrative independence,
financial autonomy, and stable leadership. Its primary objective is to
safeguard public health by conducting surveillance over products,
services, processes, ingredients, and technologies that may pose
health risks. The agency’s mission is to protect and promote public
health, intervening in risks associated with regulated products
while coordinating with other governmental entities. Additionally,
ANVISA oversees health control at ports, airports, and borders,
and engages in international relations concerning health surveil-
lance. ANVISA’s global engagement extends to its membership in
the International Council on Harmonisation of Technical Require-
ments for Registration of Pharmaceuticals for Human Use (ICH),
where it collaborates with other regulatory bodies to ensure global
health standards.
Resolution RDC 185/2001
This resolution established the classification criteria for medical
devices in Brazil, categorizing them into Classes I, II, III, and IV
based on their risk level. It also established procedures for the regis-
tration of medical products and administrative penalties, including
suspension and cancellation of registrations.77
Resolution RDC 16/2013
This resolution established good manufacturing practices for
medical devices and in vitro diagnostics, including records and
documentation controls, design controls, process and production
controls, and storage, handling, distribution, and labeling.78
Resolution RDC 36/2015
This resolution established regulations for in vitro diagnostic prod-
ucts, including the classification of risks, registration and control
systems, and labeling for instructions for use.79
Resolution RDC 751/2022
ANVISA updated Regulation No. 185/2001 to include risk
classification, notification, and registration procedures, and labeling
guidelines for medical devices and accessories. Significant changes
include expanded definitions, aligning with EU MDR, and a
revised classification system from Classes I to IV, each correspond-
ing to a specific risk level. Lower-risk devices follow simplified
pathways, while Class III and IV devices undergo registration and
are valid for 10 years. All devices require a Medical Device Tech-
nical Dossier, with a new Documentary Repository for document
storage. Notification and registration tasks are managed by the
Brazil Registration Holder (BRH). Existing manufacturers should
conduct a gap assessment against the new regulation, especially
regarding classification changes, with adjustments required by 29
February 2024, for up-classified devices.80
Oceania
Australia
Australia is a constitutional monarchy and parliamentary democ-
racy, where citizens elect representatives to the legislature, and all
governmental actions are performed in the name of the monarch.
The Australian Constitution establishes the Federal Government by
establishing three branches: Parliament, the Executive Government,
and the Judiciary. A basic primer of the Australian government sys-
tem, while out of the scope of this book, is useful in this context.81
The Development of Medical Device Regulations. During the
period leading up to 1938, the market for medicine in Australia was
largely unregulated, leading to the proliferation of medicines with
questionable therapeutic claims. In response, some state govern-
ments began to take steps to regulate these claims, while the Com-
monwealth increased controls on imported biological products. The
National Health and Medical Research Council (NHMRC) also
began pushing for national standards for labeling and emphasized
the importance of independent laboratory testing.81
From 1939 to 1988, the Australian government took addi-
tional action by enacting legislation to regulate medicine standards.
However, this was primarily focused on pharmaceuticals, with
the establishment of the National Biological Standards Labora-
tory, which was tasked with independently testing medicines on
the Australian market and regulating their manufacture. This era
marked the beginning of a more systematic approach to regulating
therapeutic goods.
The Therapeutic Goods Act 1989 and the Therapeutic
Goods Administration
From 1989 to 2007, the regulatory framework was integrated
and refined further. In 1989, the Therapeutic Goods Act was
established.82 It is a comprehensive framework for the control of
the quality, safety, efficacy, and marketing of therapeutic goods,
including both drugs and medical devices, used or sold across
Australia. The Therapeutic Goods Administration (TGA) was then
established to uphold and administer the Therapeutic Goods Act
1989 and was instrumental in creating a national system for the
regulation of therapeutic goods, which continued to grow into an
internationally harmonized regulatory system.83
The TGA’s key functions include evaluating medical devices
before they enter the Australian market, monitoring them once they
are in use, and conducting audits and inspections to ensure compli-
ance with manufacturing and operational standards.
To maintain global best practices, the TGA collaborates with
several international regulatory bodies. This cooperation helps align
Australia’s regulations with international norms, facilitates the
smooth import and export of medical devices, and ensures global
standards are met.
The Therapeutic Goods (Medical Devices) Regulations
The Therapeutic Goods (Medical Devices) Regulations 2002 in
Australia established the risk-based classification system and the
Australian Register of Therapeutic Goods (Register) that exists
today.84 The risk-based classification system categorizes medical
CHAPTER 1:
Medical Devices: A History
Agência Nacional de Vigilância Sanitária (ANVISA)
The Brazilian Health Regulatory Agency, commonly known
as ANVISA (Agência Nacional de Vigilância Sanitária), was
established in 1999 and operates under the Ministry of Health.76
ANVISA is characterized by its administrative independence,
financial autonomy, and stable leadership. Its primary objective is to
safeguard public health by conducting surveillance over products,
services, processes, ingredients, and technologies that may pose
health risks. The agency’s mission is to protect and promote public
health, intervening in risks associated with regulated products
while coordinating with other governmental entities. Additionally,
ANVISA oversees health control at ports, airports, and borders,
and engages in international relations concerning health surveil-
lance. ANVISA’s global engagement extends to its membership in
the International Council on Harmonisation of Technical Require-
ments for Registration of Pharmaceuticals for Human Use (ICH),
where it collaborates with other regulatory bodies to ensure global
health standards.
Resolution RDC 185/2001
This resolution established the classification criteria for medical
devices in Brazil, categorizing them into Classes I, II, III, and IV
based on their risk level. It also established procedures for the regis-
tration of medical products and administrative penalties, including
suspension and cancellation of registrations.77
Resolution RDC 16/2013
This resolution established good manufacturing practices for
medical devices and in vitro diagnostics, including records and
documentation controls, design controls, process and production
controls, and storage, handling, distribution, and labeling.78
Resolution RDC 36/2015
This resolution established regulations for in vitro diagnostic prod-
ucts, including the classification of risks, registration and control
systems, and labeling for instructions for use.79
Resolution RDC 751/2022
ANVISA updated Regulation No. 185/2001 to include risk
classification, notification, and registration procedures, and labeling
guidelines for medical devices and accessories. Significant changes
include expanded definitions, aligning with EU MDR, and a
revised classification system from Classes I to IV, each correspond-
ing to a specific risk level. Lower-risk devices follow simplified
pathways, while Class III and IV devices undergo registration and
are valid for 10 years. All devices require a Medical Device Tech-
nical Dossier, with a new Documentary Repository for document
storage. Notification and registration tasks are managed by the
Brazil Registration Holder (BRH). Existing manufacturers should
conduct a gap assessment against the new regulation, especially
regarding classification changes, with adjustments required by 29
February 2024, for up-classified devices.80
Oceania
Australia
Australia is a constitutional monarchy and parliamentary democ-
racy, where citizens elect representatives to the legislature, and all
governmental actions are performed in the name of the monarch.
The Australian Constitution establishes the Federal Government by
establishing three branches: Parliament, the Executive Government,
and the Judiciary. A basic primer of the Australian government sys-
tem, while out of the scope of this book, is useful in this context.81
The Development of Medical Device Regulations. During the
period leading up to 1938, the market for medicine in Australia was
largely unregulated, leading to the proliferation of medicines with
questionable therapeutic claims. In response, some state govern-
ments began to take steps to regulate these claims, while the Com-
monwealth increased controls on imported biological products. The
National Health and Medical Research Council (NHMRC) also
began pushing for national standards for labeling and emphasized
the importance of independent laboratory testing.81
From 1939 to 1988, the Australian government took addi-
tional action by enacting legislation to regulate medicine standards.
However, this was primarily focused on pharmaceuticals, with
the establishment of the National Biological Standards Labora-
tory, which was tasked with independently testing medicines on
the Australian market and regulating their manufacture. This era
marked the beginning of a more systematic approach to regulating
therapeutic goods.
The Therapeutic Goods Act 1989 and the Therapeutic
Goods Administration
From 1989 to 2007, the regulatory framework was integrated
and refined further. In 1989, the Therapeutic Goods Act was
established.82 It is a comprehensive framework for the control of
the quality, safety, efficacy, and marketing of therapeutic goods,
including both drugs and medical devices, used or sold across
Australia. The Therapeutic Goods Administration (TGA) was then
established to uphold and administer the Therapeutic Goods Act
1989 and was instrumental in creating a national system for the
regulation of therapeutic goods, which continued to grow into an
internationally harmonized regulatory system.83
The TGA’s key functions include evaluating medical devices
before they enter the Australian market, monitoring them once they
are in use, and conducting audits and inspections to ensure compli-
ance with manufacturing and operational standards.
To maintain global best practices, the TGA collaborates with
several international regulatory bodies. This cooperation helps align
Australia’s regulations with international norms, facilitates the
smooth import and export of medical devices, and ensures global
standards are met.
The Therapeutic Goods (Medical Devices) Regulations
The Therapeutic Goods (Medical Devices) Regulations 2002 in
Australia established the risk-based classification system and the
Australian Register of Therapeutic Goods (Register) that exists
today.84 The risk-based classification system categorizes medical