5
CHAPTER 1:
Medical Devices: A History
However, as medical technology advanced, the necessity for a
formal regulatory system became apparent.
Health Canada
Health Canada was established in 1993, evolving from the Depart-
ment of National Health and Welfare, which itself was set up in
1944. This transition marked the latest in a series of transformations
dating back to 1919, reflecting the ongoing development of Cana-
da’s public health infrastructure.23
Health Canada is the regulatory agency responsible for
maintaining and modernizing the Canadian healthcare system and
promoting public health. Its duties include regulating medical de-
vices, drugs, foods, environmental and pesticide safety, sanitation,
and industrial conditions. It is also responsible for disseminating
information for disease prevention, promoting healthy lifestyles,
conducting research, and overseeing public health surveillance and
response to disease outbreaks.
The Food and Drugs Act and Medical Devices
The Food and Drugs Act was initially enacted in 1920. The initial
scope was primarily focused on pharmaceuticals, based on the
more evident risks associated with drug consumption. Yet, as
medical technology evolved, the government became increasingly
aware that devices used in medical treatment also posed significant
risks if not adequately regulated.24
In 1975, the evolution of the Food and Drugs Act into a
comprehensive regulatory framework for medical devices demon-
strated a further shift towards a more proactive approach to public
health. The government realized that the growing complexity of
medical technologies and their potential risks required regulatory
measures not just for immediate safety but also to ensure long-
term reliability and effectiveness. Still, it was not until 1998 that
the regulation of medical devices took a more defined shape with
the enactment of the Medical Device Regulations.
Medical Devices Regulations (SOR/98-282)
The Medical Device Regulations were established on 16 May
1998 and officially took effect on 1 January 2003. They are the
principal regulations that govern the sale, advertisement, manu-
facturing, and importation of medical devices in Canada. These
regulations, including regulatory review where necessary, ensure
that all medical devices undergo appropriate scrutiny before they
can be made available in the Canadian market. Under the Medical
Device Regulations, medical devices are classified into four classes
based on the risk associated with their use, from Class I (lowest
risk) to Class IV (highest risk). Based on their level of risk, devices
must either apply for a medical device establishment license
(MDEL) or a medical device license (MDL). Devices under Class
II through IV must apply for an MDL, while Class I devices are
overseen through the MDEL process.25
In 2003, the Canadian Medical Devices Conformity
Assessment System (CMDCAS) was established to ensure that
certain medical devices are designed and manufactured under a
quality management system (QMS) registered and compliant with
Canadian regulations.26 In recent decades, Canada has participated
in international efforts to harmonize regulations, such as through
the International Medical Device Regulators Forum (IMDRF).
In January 2019, Canada replaced CMDCAS with the Medical
Device Single Audit Program (MDSAP), joining Australia, Brazil,
Japan, and the US. MDSAP streamlines the QMS auditing pro-
cess for medical device manufacturers by enabling a single audit to
fulfill the regulatory requirements of those jurisdictions that are a
part of the program.27
Europe
European Union
The regulation of European medical products was not introduced
until the advent of the European Economic Union (EEU) in
1957.28 The basic concept was to create a single European market
where people, products, and services could move freely across
national borders, eliminating barriers to trade between member
countries. To remove legal barriers, a new legislative technique
and strategy was implemented by the Council Resolution of 7
May 1985 on a new approach to technical harmonization and
standards, known as the New Approach Directives.29 In 1992, the
EEU was renamed the European Union (EU), reflecting that it
was no longer a purely economic union but also a political one. The
number of EU Member States has grown from 6 in 1957 to 28 in
2017. In addition, EU laws are also applicable in Norway, Iceland,
and Liechtenstein (as members of the European Economic Area).
Regulating and harmonizing laws for every product was
impractical. Old national laws that specified individual product
regulations were replaced by the New Approach Directives, which
regulated utilizing product families. Conformity to the New
Approach Directives allowed for the CE mark (an acronym for
the French “Conformite Europeenne”) to be affixed to products,
denoting that a product had met EU health, safety, and environ-
mental requirements. The CE mark is not a quality indicator nor
a certification mark for consumers but is meant to be more of a
“passport” for products. It was a visible sign for EU authorities that
the product manufacturer claimed to comply with the essential
health and safety requirements of all directives that applied to the
product.
The New Approach Directives set out a “modular” approach
for the criteria and guidelines for conformity assessment pro-
cedures. The conformity assessment modules were divided into
sections related to the products’ design phase and their production/
post-production phases. A key component of the new conformity
assessment process was the use of harmonized standards that had
to be published in the Official Journal of the European Union.30
Harmonized standards allowed for a presumption of conformity to
the legal requirements in particular directive. Often, these interna-
tional standards, produced by the Organization for International
Standards (ISO), European standards (European Norms “EN”),
European Committee for Standardization (CEN), or the Europe-
an Committee for Electrotechnical Standardization (CENELEC),
would be accompanied by an annex which described its relation-
ship to a particular New Approach Directive(s). A manufacturer
using a harmonized standard in the design and/or production/
CHAPTER 1:
Medical Devices: A History
However, as medical technology advanced, the necessity for a
formal regulatory system became apparent.
Health Canada
Health Canada was established in 1993, evolving from the Depart-
ment of National Health and Welfare, which itself was set up in
1944. This transition marked the latest in a series of transformations
dating back to 1919, reflecting the ongoing development of Cana-
da’s public health infrastructure.23
Health Canada is the regulatory agency responsible for
maintaining and modernizing the Canadian healthcare system and
promoting public health. Its duties include regulating medical de-
vices, drugs, foods, environmental and pesticide safety, sanitation,
and industrial conditions. It is also responsible for disseminating
information for disease prevention, promoting healthy lifestyles,
conducting research, and overseeing public health surveillance and
response to disease outbreaks.
The Food and Drugs Act and Medical Devices
The Food and Drugs Act was initially enacted in 1920. The initial
scope was primarily focused on pharmaceuticals, based on the
more evident risks associated with drug consumption. Yet, as
medical technology evolved, the government became increasingly
aware that devices used in medical treatment also posed significant
risks if not adequately regulated.24
In 1975, the evolution of the Food and Drugs Act into a
comprehensive regulatory framework for medical devices demon-
strated a further shift towards a more proactive approach to public
health. The government realized that the growing complexity of
medical technologies and their potential risks required regulatory
measures not just for immediate safety but also to ensure long-
term reliability and effectiveness. Still, it was not until 1998 that
the regulation of medical devices took a more defined shape with
the enactment of the Medical Device Regulations.
Medical Devices Regulations (SOR/98-282)
The Medical Device Regulations were established on 16 May
1998 and officially took effect on 1 January 2003. They are the
principal regulations that govern the sale, advertisement, manu-
facturing, and importation of medical devices in Canada. These
regulations, including regulatory review where necessary, ensure
that all medical devices undergo appropriate scrutiny before they
can be made available in the Canadian market. Under the Medical
Device Regulations, medical devices are classified into four classes
based on the risk associated with their use, from Class I (lowest
risk) to Class IV (highest risk). Based on their level of risk, devices
must either apply for a medical device establishment license
(MDEL) or a medical device license (MDL). Devices under Class
II through IV must apply for an MDL, while Class I devices are
overseen through the MDEL process.25
In 2003, the Canadian Medical Devices Conformity
Assessment System (CMDCAS) was established to ensure that
certain medical devices are designed and manufactured under a
quality management system (QMS) registered and compliant with
Canadian regulations.26 In recent decades, Canada has participated
in international efforts to harmonize regulations, such as through
the International Medical Device Regulators Forum (IMDRF).
In January 2019, Canada replaced CMDCAS with the Medical
Device Single Audit Program (MDSAP), joining Australia, Brazil,
Japan, and the US. MDSAP streamlines the QMS auditing pro-
cess for medical device manufacturers by enabling a single audit to
fulfill the regulatory requirements of those jurisdictions that are a
part of the program.27
Europe
European Union
The regulation of European medical products was not introduced
until the advent of the European Economic Union (EEU) in
1957.28 The basic concept was to create a single European market
where people, products, and services could move freely across
national borders, eliminating barriers to trade between member
countries. To remove legal barriers, a new legislative technique
and strategy was implemented by the Council Resolution of 7
May 1985 on a new approach to technical harmonization and
standards, known as the New Approach Directives.29 In 1992, the
EEU was renamed the European Union (EU), reflecting that it
was no longer a purely economic union but also a political one. The
number of EU Member States has grown from 6 in 1957 to 28 in
2017. In addition, EU laws are also applicable in Norway, Iceland,
and Liechtenstein (as members of the European Economic Area).
Regulating and harmonizing laws for every product was
impractical. Old national laws that specified individual product
regulations were replaced by the New Approach Directives, which
regulated utilizing product families. Conformity to the New
Approach Directives allowed for the CE mark (an acronym for
the French “Conformite Europeenne”) to be affixed to products,
denoting that a product had met EU health, safety, and environ-
mental requirements. The CE mark is not a quality indicator nor
a certification mark for consumers but is meant to be more of a
“passport” for products. It was a visible sign for EU authorities that
the product manufacturer claimed to comply with the essential
health and safety requirements of all directives that applied to the
product.
The New Approach Directives set out a “modular” approach
for the criteria and guidelines for conformity assessment pro-
cedures. The conformity assessment modules were divided into
sections related to the products’ design phase and their production/
post-production phases. A key component of the new conformity
assessment process was the use of harmonized standards that had
to be published in the Official Journal of the European Union.30
Harmonized standards allowed for a presumption of conformity to
the legal requirements in particular directive. Often, these interna-
tional standards, produced by the Organization for International
Standards (ISO), European standards (European Norms “EN”),
European Committee for Standardization (CEN), or the Europe-
an Committee for Electrotechnical Standardization (CENELEC),
would be accompanied by an annex which described its relation-
ship to a particular New Approach Directive(s). A manufacturer
using a harmonized standard in the design and/or production/