14 Regulatory Affairs Professionals Society (RAPS)
Fundamentals of Medical Device Regulations: A Global Perspective
devices into Classes I, IIa, IIb, III, and AIMD (Active Implant-
able Medical Devices) based on their associated risk levels, with
Class I devices posing the lowest risk and Class III the highest.
This classification system influences the rigor of the conformity
assessment process each device must undergo before receiving
TGA approval. Conformity assessment is a process that evaluates
whether a device meets the necessary regulatory requirements for
safety and efficacy. Additionally, upon this regulation, all medical
devices began to be placed on the Register before they could be
marketed in Australia. This Register provides a transparent record
of all approved devices, ensuring that only those meeting strict
standards are available to the Australian public.85
The Therapeutic Goods Regulations were then amended
in 2010, improving the understanding and expectations of the
postmarket surveillance and recalls of health products, ensuring
that any safety issues could be quickly identified and addressed.86
Definitions of health products within the regulations were clar-
ified and expanded, providing all stakeholders, including manu-
facturers and regulators, with a clear understanding of compliance
requirements. This included several clarifications for medical
device classification and the conformity assessment process, and a
re-classification scheme for certain medical devices, aligning them
more accurately with their risk levels and ensuring that higher-risk
devices underwent more rigorous evaluation and monitoring.
Administrative processes related to the registration and listing of
medical devices on the Australian Register of Therapeutic Goods
(ARTG) were also streamlined, and the TGA was granted the
ability to conduct more effective inspections, impose penalties for
non-compliance, and, if necessary, remove non-compliant devices
from the market.
The most recent update to the Therapeutic Goods Legis-
lation Amendment (2023 Measures No. 2) Regulations 2023
was approved by the Executive Council on 23 November 2023
and registered on 27 November 2023. Key amendments include
extending transitional timeframes for medical device reforms to
align with similar initiatives in the EU. These reforms also involve
the reclassification of certain medical devices, such as those in
direct contact with critical body systems, and regulations pertain-
ing to personalized medical devices. Additionally, the amend-
ments enhance the safety of medical devices used in clinical trials
by clarifying the authority of personnel to oversee trial sites and
ensure compliance with good clinical practice.87
International Medical Device Regulators Forum
(IMDRF) and Medical Device Single Audit Program
(MDSAP)
In recent decades, Australia has participated in international
efforts to harmonize regulations, such as through the IMDRF.
In 2018, Australia joined Canada, Brazil, Japan, and the Unit-
ed States. MDSAP streamlines the QMS auditing process for
medical device manufacturers by enabling a single audit to fulfill
the regulatory requirements of those jurisdictions that are a part of
the program.88
Conclusion
The regulation of medical devices is a dynamic field shaped
by historical events, technological innovations, and regional
governance. Different parts of the world have constructed unique
regulatory frameworks that address their specific challenges
and opportunities, ensuring the safety, effectiveness, and quality
of medical devices. Understanding these diverse approaches
provides insight into the continuous effort required to balance
public health protection with fostering innovation. As the med-
ical device industry evolves, ongoing international cooperation,
harmonization, and adaptation of regulatory practices will be
crucial in meeting global healthcare needs.
References
1. Branches of the U.S. Government, Current as of 20 September 2024.
Accessed 5 March 2025. https://www.usa.gov/branches-of-government
2. Department of Health and Human Services. HHS agencies and offices.
Last reviewed 28 November 2023. Accessed 11 February 2024. https://
www.hhs.gov/about/agencies/hhs-agencies-and-offices/index.html
3. Food and Drug Administration. FDA rules and regulations. Current
as of 1 June 2020. Accessed 11 February 2024. https://www.fda.gov/
regulatory-information/fda-rules-and-regulations
4. 21 CFR. Food and Drugs. Up to date as of 15 February 2024.
Accessed 11 February 2024. https://www.ecfr.gov/current/title-21
5. Food and Drug Administration. Search for FDA guidance documents
Current as of 11 February 2024. Accessed 11 February 2024. https://
www.fda.gov/regulatory-information/search-fda-guidance-documents
6. FDA’s Origin. Current as of 1 February 2018. Accessed 11 February
2024. https://www.fda.gov/about-fda/changes-science-law-and-
regulatory-authorities/fdas-origin
7. Food and Food Adulterants. US Department of Agriculture Division
of Chemistry. Accessed 14 March 2025. https://archive.org/details/
foodsfoodadulter13unse/page/n1/mode/2up
8. Food and Drug Administration. Part 1: The 1906 Food and Drug
Act and its enforcement. Current as of 24 April 2019. Accessed 11
February 2024. https://www.fda.gov/about-fda/changes-science-law-
and-regulatory-authorities/part-i-1906-food-and-drugs-act-and-its-
enforcement
9. Milestones in U.S. Food and Drug Law. Current as of 30 January
2023. Accessed 16 February 2024. https://www.fda.gov/about-fda/fda-
history/milestones-us-food-and-drug-law
10. Rados C. Medical device and radiological health regulations come of
age. FDA Consumer Magazine. Published January-February 2006.
Current as of 31 January 2018. Accessed 16 February 2024. https://
www.fda.gov/about-fda/histories-product-regulation/medical-device-
radiological-health-regulations-come-age
11. Food and Drug Administration. Part II: 1938, Food, Drug, Cosmetic
Act. Updated 27 November 2018. Accessed 5 March 2025. https://
www.fda.gov/about-fda/changes-science-law-and-regulatory-
authorities/part-ii-1938-food-drug-cosmetic-act
12. Ballentine C. Taste of Raspberries, Taste of Death: The 1937 Elixir
Sulfanilamide Incident. FDA Consumer Magazine. Published June
198. Accessed 16 February 2024. https://www.fda.gov/files/about%20
Fundamentals of Medical Device Regulations: A Global Perspective
devices into Classes I, IIa, IIb, III, and AIMD (Active Implant-
able Medical Devices) based on their associated risk levels, with
Class I devices posing the lowest risk and Class III the highest.
This classification system influences the rigor of the conformity
assessment process each device must undergo before receiving
TGA approval. Conformity assessment is a process that evaluates
whether a device meets the necessary regulatory requirements for
safety and efficacy. Additionally, upon this regulation, all medical
devices began to be placed on the Register before they could be
marketed in Australia. This Register provides a transparent record
of all approved devices, ensuring that only those meeting strict
standards are available to the Australian public.85
The Therapeutic Goods Regulations were then amended
in 2010, improving the understanding and expectations of the
postmarket surveillance and recalls of health products, ensuring
that any safety issues could be quickly identified and addressed.86
Definitions of health products within the regulations were clar-
ified and expanded, providing all stakeholders, including manu-
facturers and regulators, with a clear understanding of compliance
requirements. This included several clarifications for medical
device classification and the conformity assessment process, and a
re-classification scheme for certain medical devices, aligning them
more accurately with their risk levels and ensuring that higher-risk
devices underwent more rigorous evaluation and monitoring.
Administrative processes related to the registration and listing of
medical devices on the Australian Register of Therapeutic Goods
(ARTG) were also streamlined, and the TGA was granted the
ability to conduct more effective inspections, impose penalties for
non-compliance, and, if necessary, remove non-compliant devices
from the market.
The most recent update to the Therapeutic Goods Legis-
lation Amendment (2023 Measures No. 2) Regulations 2023
was approved by the Executive Council on 23 November 2023
and registered on 27 November 2023. Key amendments include
extending transitional timeframes for medical device reforms to
align with similar initiatives in the EU. These reforms also involve
the reclassification of certain medical devices, such as those in
direct contact with critical body systems, and regulations pertain-
ing to personalized medical devices. Additionally, the amend-
ments enhance the safety of medical devices used in clinical trials
by clarifying the authority of personnel to oversee trial sites and
ensure compliance with good clinical practice.87
International Medical Device Regulators Forum
(IMDRF) and Medical Device Single Audit Program
(MDSAP)
In recent decades, Australia has participated in international
efforts to harmonize regulations, such as through the IMDRF.
In 2018, Australia joined Canada, Brazil, Japan, and the Unit-
ed States. MDSAP streamlines the QMS auditing process for
medical device manufacturers by enabling a single audit to fulfill
the regulatory requirements of those jurisdictions that are a part of
the program.88
Conclusion
The regulation of medical devices is a dynamic field shaped
by historical events, technological innovations, and regional
governance. Different parts of the world have constructed unique
regulatory frameworks that address their specific challenges
and opportunities, ensuring the safety, effectiveness, and quality
of medical devices. Understanding these diverse approaches
provides insight into the continuous effort required to balance
public health protection with fostering innovation. As the med-
ical device industry evolves, ongoing international cooperation,
harmonization, and adaptation of regulatory practices will be
crucial in meeting global healthcare needs.
References
1. Branches of the U.S. Government, Current as of 20 September 2024.
Accessed 5 March 2025. https://www.usa.gov/branches-of-government
2. Department of Health and Human Services. HHS agencies and offices.
Last reviewed 28 November 2023. Accessed 11 February 2024. https://
www.hhs.gov/about/agencies/hhs-agencies-and-offices/index.html
3. Food and Drug Administration. FDA rules and regulations. Current
as of 1 June 2020. Accessed 11 February 2024. https://www.fda.gov/
regulatory-information/fda-rules-and-regulations
4. 21 CFR. Food and Drugs. Up to date as of 15 February 2024.
Accessed 11 February 2024. https://www.ecfr.gov/current/title-21
5. Food and Drug Administration. Search for FDA guidance documents
Current as of 11 February 2024. Accessed 11 February 2024. https://
www.fda.gov/regulatory-information/search-fda-guidance-documents
6. FDA’s Origin. Current as of 1 February 2018. Accessed 11 February
2024. https://www.fda.gov/about-fda/changes-science-law-and-
regulatory-authorities/fdas-origin
7. Food and Food Adulterants. US Department of Agriculture Division
of Chemistry. Accessed 14 March 2025. https://archive.org/details/
foodsfoodadulter13unse/page/n1/mode/2up
8. Food and Drug Administration. Part 1: The 1906 Food and Drug
Act and its enforcement. Current as of 24 April 2019. Accessed 11
February 2024. https://www.fda.gov/about-fda/changes-science-law-
and-regulatory-authorities/part-i-1906-food-and-drugs-act-and-its-
enforcement
9. Milestones in U.S. Food and Drug Law. Current as of 30 January
2023. Accessed 16 February 2024. https://www.fda.gov/about-fda/fda-
history/milestones-us-food-and-drug-law
10. Rados C. Medical device and radiological health regulations come of
age. FDA Consumer Magazine. Published January-February 2006.
Current as of 31 January 2018. Accessed 16 February 2024. https://
www.fda.gov/about-fda/histories-product-regulation/medical-device-
radiological-health-regulations-come-age
11. Food and Drug Administration. Part II: 1938, Food, Drug, Cosmetic
Act. Updated 27 November 2018. Accessed 5 March 2025. https://
www.fda.gov/about-fda/changes-science-law-and-regulatory-
authorities/part-ii-1938-food-drug-cosmetic-act
12. Ballentine C. Taste of Raspberries, Taste of Death: The 1937 Elixir
Sulfanilamide Incident. FDA Consumer Magazine. Published June
198. Accessed 16 February 2024. https://www.fda.gov/files/about%20