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Received February 14 2024, accepted December 15, 2024, date of publication February 15 2025.

Original Research Article

A Study on the Legal Environment of Medical Devices and 
Enhancing the Regulatory System

Gerelt-Od Namdag1, Munkh-Erdene Luvsan1, Amarsaikhan Dashtseren2,*

1 Department of Health Policy, School of Public Health, Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia.
2 Department of Preventive Medicine, School of Public Health, Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia.

* Corresponding Author Email: amarsaikhan.d@mnums.edu.mn

ABSTRACT

The regulation of medical devices is governed by the Law on Health, the Law on Medicines and Medical Devices, and the Law 
on Metrology. While these laws provide definitions of key terms, they lack detailed regulations. The Law on Health addresses 
issues related to special licenses, while the Law on Metrology covers metrological inspections. According to the “Methodology 
for Assessing the Consequences of the Implementation of Legislation”, as approved by Appendix 6 of Government Resolution 
No. 59 of 2016, the implementation of these laws, including the Law on Medicines and Medical Devices, the Law on Health, and 
the Law on Metrology, has not fully aligned with reality. This misalignment has failed to regulate certain essential relationships, 
leading to negative societal impacts. Consequently, we assessed the implementation and consequences of these laws, considering 
the lag between social changes and legal developments. Additionally, comparing medical device regulations with the standard 
regulations of countries around the world revealed several differences, starting from the definitions of key terms. We concluded 
that there is a need to improve the legal and regulatory environment to establish unified policies and regulations for registration, 
quality, safety, optimal asset planning, and maintenance management, particularly for medical equipment.

Keywords—Specialists, Consequences, Equipment, Medical devices, Medical supplies, Regulation.            

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Namdag, Luvsan, Dashtseren: A Study on the Legal Environment of Medical Devices and Enhancing the Regulatory System

J Global Clinical Engineering Vol.7 Issue 1: 2025 26

INTRODUCTION

The medical device market in Mongolia is small, which 
limits the potential for major manufacturers to establish 
businesses in the country. Mongolia does not produce any 
medical devices, except for disposable syringes and a few 
other minor items. As a result, nearly all medical devices 
are imported from various countries and manufacturers. 
This situation leads to many unregistered medical devices 
of uncertain quality. Supplying government hospitals 
with modern, high-quality, safe, and reliable equipment 
and ensuring regular preventive maintenance and repair 
services has been one of the biggest challenges in the 
Mongolian healthcare sector. 

State budget investments in medical equipment have 
varied over the years: in 2019, USD 2.4 million were al-
located; in 2020, USD 11.2 million; in 2021, USD 32.7 
million; in 2022, USD 4.3 million; and in 2023, USD 3.5 
million. Before 2017, the budget for medical equipment 
maintenance was included in the organization’s opera-
tional expenditure. However, starting in 2018, the main-
tenance and service costs for major technologies, such as 
magnetic resonance imaging (MRI) scanners, computed 
tomography (CT) scanners, and angiography machines, 
were separately allocated within the state budget. In 
2018, USD 0.7 million were dedicated to this purpose, 
followed by USD 0.8 million in 2019, USD 1.1 million in 
2020, and USD 1.6 million in 2021. From 2022 onward, 
due to performance-based financing, a separate budget 
for these services is no longer allocated.1

Many developing countries today face similar challenges 
with medical devices due to their complex nature, as they 
combine mechanical, electronic, software, and chemical 
components. This complexity necessitates a higher level 
of safety and an improved regulatory system. Medical 
devices play a crucial role in diagnosing, preventing, 
monitoring, and treating diseases. Unlike drugs or biolog-
ics, medical devices can range from simple devices that 
pose little or no risk to the user (e.g., a suction pump) to 
life-sustaining devices (e.g., a pacemaker). The solution 
to these challenges lies in developing a comprehensive 
regulatory system for medical devices.

Regulatory systems for medical devices are generally 
less developed than those for other health products such 

as medicines or vaccines. A desk survey conducted in 
2015–2016 revealed that 58% of World Health Organiza-
tion (WHO) member states had some form of regulation 
for medical devices, even if limited.2 Many governments, 
including Mongolia, that have drafted medical device regu-
lations have made limited progress in implementing them.

In Mongolia, medical device regulatory systems are 
less developed than in other countries. Having an ap-
propriate and comprehensive policy that guides medical 
equipment selection, procurement, and maintenance in 
compliance with international standards. While Mongolia 
has some ministerial orders and policy documents related 
to medical devices and health technology, there is still a 
need for improvement. Additional regulatory systems are 
required, including import control, product registration, 
classification, packaging and labeling, advertising, use, 
and disposal.

METHODOLOGY 

We assessed the implementation of laws and regula-
tions related to medical device regulation to identify 
areas for improving the regulatory system. We reviewed 
relevant articles, audit and evaluation reports, and other 
documents from authorized organizations to analyze the 
practical compliance of laws and regulations with their 
provisions and compare them with the most significant 
and influential international standards. Additionally, 
recommendations, documents, and standards from the 
WHO and international regulatory organizations were 
analyzed. Comparative studies were conducted on the 
regulations of other countries in relation to Mongolia’s 
legal environment. Data collection involved meetings, 
discussions, and feedback exchanges using the following 
methods.

The descriptive study included audit, monitoring, 
assessment reports, news from authorized organiza-
tions, and recommendations, documents, standards, and 
regulations from the WHO and international regulatory 
organizations. Additionally, three focus group interviews 
were conducted, involving 26 participants divided into 
three groups: 9 medical equipment engineers from local 
healthcare facilities, 8 university faculties, and 9 medical 
equipment engineers from the private sector. The fo-
cus group interviews were analyzed using the content 



27 J Global Clinical Engineering Vol.7 Issue 1: 2025

  Namdag, Luvsan, Dashtseren: A Study on the Legal Environment of Medical Devices and Enhancing the Regulatory System

analysis method to assess the implementation of legal 
documents related to medical equipment, the quality and 
accessibility of equipment, the capacity and adequacy of 
human resources, and the challenges encountered while 
implementing the laws.

RESULTS

The WHO defines “medical devices” as a broad category 
encompassing items ranging from small medical instru-
ments and supplies to large diagnostic and therapeutic 
equipment.3                      

The International Medical Device Regulators Forum 
(IMDRF)/GHTF also defines “medical devices” as encom-
passing a wide range of products, from relatively simple 
non-implantable devices, such as tongue depressors, 
thermometers, blood pressure monitors, stethoscopes, 
scales, disposable gloves, wound dressings, hospital beds, 
and crutches, to highly advanced imaging diagnostic de-
vices and implants. They recommend classifying medical 
devices to patients and medical professionals based on 
their risk level, with appropriate regulations tailored to 
each category.4,5  

The IMDRF is a voluntary coalition of regulatory 
authorities that fosters international collaboration in 
regulating medical devices.

 Established in 2011 as a part of the Global Harmoni-
zation Task Force (GHTF), the IMDRF aims to harmonize 
and enhance the global regulation of medical devices.

In the countries of the WHO Western Pacific Region, 
including Australia, Japan, Korea, China, and the Philippines, 
medical devices are classified based on the risk they pose 
to patients and medical professionals. These classifications 
include Categories A, B, C, and D, and Classes Ⅰ, Ⅱ A, Ⅱ B, 
and Ⅲ. Regulations are tailored to these classifications, 
with high-risk devices, such as those in Categories C, D, or 
Classes Ⅱ B, and Ⅲ, requiring registration, while lower-
risk devices are listed separately.6–10 

These classifications align with the “Global Model 
Regulatory Framework for Medical Devices” issued by WHO11 
and the general regulatory models provided by IMDRF.

In terms of the legislation in Mongolia, the regulation of 
medical devices is as follows: The Law on Health provides 
definitions of four terms: 3.1.13 “medical equipment”, 
3.1.14 “medical instrument”, 3.1.15 “accessories for 
medical equipment”, and 3.1.16 “prosthesis”, and Article 
19 of the law includes a group of provisions related to 
licenses to engage in healthcare activities. The Law on 
Medicines and Medical Devices defines two terms: 3.1.4 
“diagnostic device” and 3.1.5 “medical device”, and Article 
8.1.1 of the Law on Metrology regulates them separately.

According to the descriptive study, within the framework 
of the above legislation, the following standards have 
been approved: Structure and Operation Standards-7, 
Medical Equipment Standards-16, Order of the Deputy 
Prime Minister of Mongolia-1, Order of the Minister of 
Health-14, and Order of the Director of the Mongolian 
Agency for Standard Metrology-2. 

In a survey on implementing laws and regulations 
related to medical equipment, 86.1% of respondents said 
that a state inspection and regulatory system for medical 
equipment had not been established. 91.7% indicated that 
a legal framework for regulating medical equipment was 
absent. 91.9% reported no legal framework for ensuring 
the quality and safety of medical equipment. 91.7% said a 
legal framework for the optimal planning and regulation 
of medical equipment assets was not established. 97.3% 
indicated a legal framework for regulating medical 
equipment maintenance and service management was not 
in place. 75% of respondents said that a state inspection 
and regulatory system for medical equipment had been 
established, while 25% disagreed. A total of 25.7% felt 
that regulating medical equipment licenses was sufficient, 
while 74.3% believed it was insufficient.

Implementation of Legal Documents and Reflection of 
Stakeholders’ Feedback

There is limited regulation related to medical equipment 
in sectoral laws, and existing regulations are scattered 
across individual laws. Although healthcare facilities follow 
Ministerial Order No. 439 of 2006, the implementation of 
this order varies depending on the hierarchy of healthcare 
facilities, with local areas facing particular challenges. It 



Namdag, Luvsan, Dashtseren: A Study on the Legal Environment of Medical Devices and Enhancing the Regulatory System

J Global Clinical Engineering Vol.7 Issue 1: 2025 28

are not always included, and it is emphasized that the 
participation of other professionals is also crucial.

Equipment Quality, Availability, and Regular 
Maintenance

Investment and supply of medical equipment have 
improved due to the coronavirus pandemic. However, the 
lack of routine maintenance, inadequate funding planning, 
and the pressure to operate in high-demand conditions 
contribute to increased equipment damage.

While performance financing and management priva-
tization have positively impacted equipment supply, some 
hospitals are forced to cut their maintenance budgets to 
remain profitable

“A hospital can only attract customers if it has both 
good equipment and skilled specialists.” (Engineer of 
the medical equipment, Healthcare facility)

“Our hospital has a budget of USD 0.6 million for normal 
operations, covering everything from vehicles and build-
ings to computers. However, only about USD 500-600 are 
allocated for hospital equipment, which is insufficient 
even to cover the spare parts for a single device.” (En-
gineer of the medical equipment, Healthcare facility)

“There is no stock of spare parts for the equipment, and 
availability is always uncertain. The order is constantly 
dependent on someone else. After the equipment is installed, 
if a failure occurs later, the spare parts may already be 
outdated, or the equipment may no longer be produced. 
As a result, we engineers are left with no choice but to 
resort to a ‘Mongolian way’ of handling it.” (Engineer of 
the medical equipment, Supply organization)1

Medical equipment purchases are often organized by 
unqualified individuals without obtaining quotes based 
on technical specifications. As a result, the manufacturer 
is often unknown, and expensive, substandard equipment 
is frequently purchased.

“There was an instance where a company selling toys in 
the market won the tender to supply CPAP machines for 
infants, claiming there were no professionals available 
for the local tender. When the equipment was delivered, 
two salesmen—who were not professionals at all—came 

is emphasized that human resources and room require-
ments are insufficient in these areas. In private healthcare 
facilities, regulations are created based on the internal 
rules and regulations of the institution, which prioritize 
customer requests. Since the rules and regulations con-
cerning equipment regulation are separate, there is a 
recognized need for an integrated legal framework. This 
would involve consolidating and updating the existing 
regulations, including Ministerial Order No. 439 of 2006, 
Ministerial Order No. 404 of 2006, and MNS5097:2017 
General Hospital Structure and Operation Standards.

Ministerial Order No. 439 of 2006 states that there should 
be 1 engineer for every 100 pieces of equipment. How-
ever, it is necessary to define which types of equipment 
should be included in the 100-piece count. Additionally, it 
should be clarified that one engineer should specifically 
be assigned to high-cost equipment, and there needs to 
be clear criteria for identifying what qualifies as high-
cost equipment. Overall, an integrated legal regulation 
is needed, rather than relying solely on Ministerial Order 
No. 439 of 2006.” (Engineer of the medical equipment, 
Healthcare facility)

“In the MNS5097:2017 standard, equipment is evaluated 
as either present or absent. For example, a hospital bed 
is considered ‘present’ even if it is broken. We would like 
to change this evaluation to a numerical system, where 
the condition of the equipment is assessed with plus or 
minus signs, rather than simply being counted as pres-
ent or absent. A numerical evaluation would provide a 
more realistic assessment of the equipment’s status.” 
(Engineer of the medical equipment, Healthcare facility)

“It would be beneficial to include criteria for buildings, 
rooms, and human resources in the accreditation stan-
dards, so that these aspects can be properly evaluated.” 
(Engineer of the medical equipment, Healthcare facility)

“In the future, the regulations should require the medi-
cal equipment manuals in a simplified format with two 
categories: user and engineering.” (Engineer of the medi-
cal equipment, Pharmaceutical supply organization)1

Representatives from faculties and researchers have 
recently been involved in developing policy documents. 
However, representatives of engineers and technicians 



29 J Global Clinical Engineering Vol.7 Issue 1: 2025

  Namdag, Luvsan, Dashtseren: A Study on the Legal Environment of Medical Devices and Enhancing the Regulatory System

to hand it over.” (Engineer of the medical equipment, 
Healthcare facility)

“It is difficult to obtain spare parts for expensive equip-
ment, and it would be beneficial if a certain percentage 
of the budget received from insurance were allocated 
specifically for spare parts.” (Engineer of the medical 
equipment, Healthcare facility)1

It is believed that the equipment registration system 
needs to be updated.

Human Resource Capacity and Accessibility

Four universities train medical equipment engineers 
and technicians, with an employment rate of 95%. How-
ever, the high workload, part-time work, low salaries and 
benefits (which are set for non-medical professionals), 
and the lack of opportunities for postgraduate training 
and specialization contribute to a shortage of human 
resources, particularly in public hospitals and rural areas.

“There should be one engineer for every 100 pieces 
of medical equipment, but in reality, one engineer is 
responsible for 200–300 pieces of medical equipment.” 
(University professor)

“Our hospital has over 600 pieces of medical equipment, 
and we have one engineer and two technicians work-
ing here. However, there are no engineers specifically 
responsible for CT, hemodialysis, and oxygen equipment, 
so three people are handling these tasks. Additionally, 
there is extra work related to Occupational Safety and 
Hygiene (OSH).” (Engineer of the medical equipment, 
Healthcare facility)

“We are performing tasks similar to surgeries, such as 
assisting with hemodialysis, and working with CT, yet we 
are paid at the Government Service (GS) level. Therefore, 
we want to be included in the GS of the Health Sector.” 
(Engineer of the medical equipment, Healthcare facility)

“There are many people who don’t fully understand the 
responsibilities of a medical equipment engineer or what 
their role should entail. They assign tasks to engineers 
simply because the work is related or similar.” (Engineer 
of the medical equipment, Healthcare facility)

“We want to hire new specialists, but they are not com-
ing to local areas. Students graduating from private 
universities are entering engineering fields, not medical 
technology. Additionally, graduates often lack the abil-
ity to distinguish between different types of equipment. 
Therefore, we need to focus on improving the quality of 
training.” (Engineer of the medical equipment, Health-
care facility)1

Medical equipment engineers often have to take on 
various additional tasks due to the ambiguity of their 
responsibilities and are frequently employed as OSH 
staff. Medical equipment engineers can be compensated 
through the Health Sector Government Service (GS).

DISCUSSION

Based on the recommendations from the WHO and 
international regulatory bodies, as well as the legal 
frameworks related to the regulation of medical devices 
and other products in various countries, a wide range 
of products, from small medical instruments to large 
diagnostic and therapeutic equipment, are defined as 
“medical devices”. These devices are then classified as 
A, B, C, and D, or Class Ⅰ, Class Ⅱ A, Class Ⅱ B, and Class 
Ⅲ, based on the level of risk they pose to patients and 
medical professionals. Regulations are being developed 
according to these categories, including the registration 
of high-risk products, such as those in categories C, D, or 
Class Ⅱ B, and Class Ⅲ, while other products are listed 
separately in the remaining categories.

The survey, conducted among medical equipment 
engineers, technicians, representatives of supply orga-
nizations, and faculties regarding the implementation of 
legislation, included 35–37 participants in each group. The 
findings indicate that the legal and regulatory framework 
concerning medical equipment is insufficiently developed, 
and state inspection and regulation are weak.

When comparing the regulations on medical equip-
ment and other products included in major healthcare 
sector laws in our country with the standard regulations 
on “medical devices” in countries around the world, dif-
ferences are evident, starting with the definition of the 
term. Establishing a legal framework for integrated policies 
and regulations covering medical equipment registration, 



Namdag, Luvsan, Dashtseren: A Study on the Legal Environment of Medical Devices and Enhancing the Regulatory System

J Global Clinical Engineering Vol.7 Issue 1: 2025 30

quality, safety, rational asset planning, and maintenance 
management is essential.

CONCLUSION

When comparing the regulations related to medi-
cal devices in Mongolia, particularly those concerning 
medical equipment, with the WHO recommendations, the 
IMDRF general regulatory models, and the regulations of 
countries such as Australia, Japan, Korea, China, and the 
Philippines significant differences emerge. These include 
discrepancies in the definitions of terms, the absence of a 
classification system for medical devices, a lack of post-
market quality surveillance, and no regulations regard-
ing packaging, labeling, advertising, or proper disposal. 
However, the regulations for importing medical devices 
through licensed suppliers are in line with the medical 
device regulations of the aforementioned countries and 
WHO recommendations.

AUTHOR CONTRIBUTIONS

Conceptualization, A.D., M-E.L., G-O.N. ;Methodology, 
A.D., M-E.L.; Formal Analysis, A.D., G-O.N.; Writing – Original 
Draft Preparation, G-O.N.; Writing – Review & Editing, A.D., 
M-E.L.; Supervision, A.D.; Project Administration, M-E.L.; 
Funding Acquisition, G-O.N.

ACKNOWLEDGMENTS
Not applicable.

FUNDING
This research received no external funding.

DATA AVAILABILITY STATEMENT
Not applicable.

CONFLICTS OF INTEREST
The authors declare they have no competing interests.

ETHICS APPROVAL AND CONSENT TO PARTICIPATE
The study methodology was reviewed and approved 

by the Research Ethics and Monitoring Committee of the 
Mongolian National University of Medical Sciences during 
its meeting on January 21, 2022 (Approval No. 2022/3-01).

CONSENT FOR PUBLICATION
Not applicable.

FURTHER DISCLOSURE
Part of the findings from this study, titled “Assessment 

of the Implementation of Medical Equipment Policy in 
Mongolia”, authored by Gerelt-Od Namdag, Munkh-Erdene 
Luvsan, and Amarsaikhan Dashtseren, was presented 
at the 5th International Clinical Engineering and Health 
Technology Management Congress (ICEHTMC), held from 
November 11 to 23, 2023. 

Additionally, the abstract of this study was published 
in the Global Clinical Engineering Journal (GCEJ) Special 
Issue 5.

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