The comparison in medical device regulation in china and us challenges and opportunities
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Transcript of The comparison in medical device regulation in china and us challenges and opportunities
1
The Comparison in
Medical Device
Regulation in China and
US
Challenges and Opportunities
Mingzi Deng
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Contents
1. Background - Rapidly developing China ................................................................ 1
2. Chinese Medical Device Industry Snapshot ........................................................... 2
2.1 The Current Medical Device Market ............................................................ 2
2.2 Forecast and Potential Market ...................................................................... 2
2.3 Where is the medical device industry located? ............................................ 3
2.4 Where are the medical devices imported from? ........................................... 4
3. Medical Devices Regulatory Authority in China and US ....................................... 4
3.1 Medical Devices Regulatory Authority In China ......................................... 4
3.2 Medical Devices Regulatory Authority In US ............................................. 5
3.3 The Comparison of SFDA and FDA structure ............................................. 6
4. The Comparison of Medical Device Definition...................................................... 7
4.1 The Definition of Medical Device in China ................................................. 7
4.2 The Definition of Medical Device in US ..................................................... 8
4.3 The Comparison of Medical Device Definition ........................................... 9
5. The Comparison of Classifications of the Medical Device .................................. 10
5.1 The Classification of Medical Devices in China ........................................ 10
5.2 The Classification of Medical Device in US .............................................. 10
5.3 The Comparison of Classification of Medical Devices .............................. 11
6. The Differences of Medical Devices Administration System in China and US ... 12
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6.1 The Legal Status ......................................................................................... 12
6.2 The Administration Status .......................................................................... 13
6.3 Opening Information .................................................................................. 14
6.4 Dealing With Adverse Events ..................................................................... 14
7. How to Improve the Chinese Medical Device Registration System..................... 15
7.1 Establish and Standardize the Nomenclature of Medical Devices ............. 15
7.2 Adjustment of the Product Classification. .................................................. 16
7.3 Scientific Clinical Trails for Medical Devices ........................................... 16
8. Challenges in Chinese Medical Devices Industry ................................................ 17
8.1 Standards in different levels are different ................................................... 17
8.2 Laws and Regulations are Constantly Changing ........................................ 17
8.3 Limited Official Announcement in English ............................................... 18
8.4 Much more Complex Relationships between Chinese Industry and
Government........................................................................................................... 18
9. Opportunities in Chinese Medical Devices Industry ............................................ 19
10. Conclusion ............................................................................................................ 19
References .................................................................................................................... 21
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1
1. Background - Rapidly developing China
China has the largest population
in the world, which is estimated at
more than 1.3 billion. Since opening
the economy to the West in 1978,
China’s economy has had an
unbelievable growth in these past 30 years. In the last decade, China has kept a rapid
GDP (Gross Domestic Product) growth rate at approximately 10%. According to the
data from the World Bank (Fig.1), from 2003 to 2008, China keeps a growth rate of
GAP over 9%.
In 2009, China’s GDP is 4984 billion
USD (The World Bank, 2009), and in this
year, China’s GDP is estimated to 5738
USD (EBI, 2007). Although the per capita
wealth is still low based on the large
population, China still is one of several
countries which can keep economic growth during the financial crisis. Figure 2 shows
the export and import levels in recent years. It is obviously that the trade level
quadrupled from 2002 to 2008 (The Word Bank, 2009). Based on its rapid
development and huge population, China has the potential to be an important part of
the global market, which includes the medical device market.
Figure 1
Figure 2
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2. Chinese Medical Device Industry Snapshot
2.1 The Current Medical Device Market
It is obviously that China is a very potential market, so how is the current
medical device market going? China is a large market, but how big it is, several
reports give us different answers. According to the data from Osec Business Network
Switzerland (OBNS), China’s medical device market in 2005 was 6.2 billion USD
(OBNS, 2007). Based on the Espicom Business Intelligence (EBI) estimated, it was
13.7 billion USD in 2006, with a 12.9% increasing from the last year (EBI, 2007). It
means that EBI estimated the China’s market as 12.1 billion USD, which is doubled
as the OBNS’s result. Otherwise, according to the report from the National
Development and Reform Commission (NDRC), in 2004, the medical device market
size was 6.6 billion USD; in 2005, it was 7.3 billion USD (NDRC, 2005).
2.2 Forecast and Potential Market
The three reports mentioned in last part have three different results, because
these are all independent research. Generally speaking, the report from NDRC should
be more authoritative as a Chinese official report. Although it does not have a unified
result, there’s one thing in common – all these report agreed that China is a very
potential market. EBI predicted the annual growth rate of the market in the period
2006-2011 is 11.1% (EBI, 2007); NDRC said it keeps a growth rate as 9 percent per
year (NDRC, 2005); and according to the data from OBNS, the supply of medical
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device in Chinese market only met approximately 60 percent of the demand from
2003 to 2005, despite the numbers of manufacturers increased 19% from 356 in 1985
to 10,447 in 2004 (See Figure 3; OBNS, 2007).
2.3 Where is the medical device industry located?
As the most populated country in the world, China has several economic
developing clusters, which is also related to the regional population. For instance, in
2007, according to the official data, Guangdong province had the largest population as
94.5 million people, equal as 7.2% of the total, and the Pearl River Delta, as one of
the famous industry zone in China, is in there. Eastern China, which is the most
populated region in the country, inhabits 379.8 million people, and includes the
Yangtze River Delta and the Circum-Bohai-Sea Region. The Pearl River delta,
Figure 3
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Yangtze River delta and the Circum-Bohai-Sea Region are the areas where the
medical device industry concentrates in. The sales income and output value in these
three regions account for over 80% of the national total (EBI, 2007; Report, 2009).
2.4 Where are the medical devices imported from?
“In the first half of 2007, the
top countries for China's medical
device imports remained the
United States, Japan and Germany.
China imported 580 million USD
worth of medical device from the
US, an increase of 11.15% over the
previous year; 350 million USD from Germany, an increase of 16.33%; and 330
million USD from Japan, a drop of 3.17%. In fact, 65.26% of all China's medical
device imports came from these three countries (See Figure 4; China, 2007).”
3. Medical Devices Regulatory Authority in China and US
3.1 Medical Devices Regulatory Authority In China
The main medical devices regulatory authorities in China include the State Food
and Drug Administration (SFDA), General Administration of Quality Supervision,
Inspection and quarantine (AQSIQ), Ministry of Health (MOH) and Department of
Commerce (DOC). The SFDA is mainly responsible for the medical devices
Figure 4
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registration and supervision. The AQSIQ’s main responsibility is to supervise the
medical devices market, especially the import and export parts. The MOH is in charge
of supervising all the hospitals and healthcare centers. The DOC is responsible for the
macroeconomic regulation and control, and the policy implement on the medical
device industry.
There are two departments in SFDA related to the medical device – Department
of Medical Devices and the Inspection Bureau. The Department of Medical Devices is
responsible for the medical devices research and producing progress. The Inspection
Bureau supervises the process of medical devices distribution and using, and punishes
the manufacturers who build the unlicensed medical devices. These two departments
have their own responsibility, but also cooperate with each other, in order to ensure
the safety and effectiveness of the medical devices.
There are 5 offices under the Department of Medical Devices – the General
Office, the Registration Office I, and II, the Office of surveillance of manufacturing
and distribution, and the Office of Device Research and Evaluation. There are 5
offices under the Inspection Bureau – the General Office and the Inspection Office I,
II, III and IV. The Inspection Office II is the one who punishes the manufacturers who
build the unqualified medical devices (SFDA, 2010).
3.2 Medical Devices Regulatory Authority In US
The Food and Drug Administration (FDA) is one of the most respected
administrations in the world with a long history in the United States. The FDA
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compromises several offices and centers. In FDA, Center for Devices and
Radiological Health (CDRH) is the medical devices regulatory authority. It includes
the Office of the Center Director, the Office of Communication, Education, and
Radiation Programs, the Office of Compliance, the Office of Device Evaluation, the
Office of in Vitro Diagnostic Device Evaluation and Safety, the Office of
Management Operations, the Office of Science and Engineering Laboratories and the
Office of Surveillance and Biometrics.
There are other important offices in the FDA, which enforces the laws related to
medical devices and other products that the FDA regulates, called the Office of
Regulatory Affairs (ORA). It is considered the "eyes and ears" of the agency, it
includes 5 regional offices and 20 district offices; it is kind of similar as the
Investigation Bureau in the SFDA in China (About the CDRH, 2010).
3.3 The Comparison of SFDA and FDA structure
Based on the different national status, there is no one-to-one correspondence
between the departments in SFDA and FDA, although the main purpose is the same –
to protect and promote public health. Therefore, based on the same purpose and the
different national status, we can only know which departments have the similar
responsibilities. For instance, the Office of Regulatory Affairs (ORA) in FDA has the
similar responsibilities as the Department of Commerce (DOC) and part of the
Investigation Bureau; the Office of Device Evaluation, the Office of in Vitro
Diagnostic Device Evaluation and Safety, the Office of Science and Engineering
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Laboratories in FDA are similar as the Office of Device Research and Evaluation in
SFDA; the Office of Surveillance and Biometrics in FDA is in part similar as the
Office of surveillance of manufacturing and distribution in SFDA (See Figure 5).
Actually, it might not be suitable to compare these different departments in FDA and
SFDA, because the different registration and regulation system, although they have
the same purpose.
4. The Comparison of Medical Device Definition
4.1 The Definition of Medical Device in China
According to the Regulations for the Supervision and Administration of Medical
Devices (Decree of the State Council No. 276) (Regulations, 2000):
Any instrument, apparatus, appliance, material, or other article whether used
Figure 5
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alone or in combination, including the software necessary for its proper application. It
does not achieve its principal action in or on the human body by means of
pharmacology, immunology or metabolism, but which may be assisted in its function
by such means; the use of which is to achieve the following intended objectives:
1) Diagnosis, prevention, monitoring, treatment or alleviation of disease;
2) Diagnosis, monitoring, treatment, alleviation of or compensation for an injury
or handicap conditions;
3) Investigation, replacement or modification for anatomy or a physiological
process;
4) Control of conception.
4.2 The Definition of Medical Device in US
FDA defines a medical device as "an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article, including a
component part, or accessory which is:
1) recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
2) intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
3) intended to affect the structure or any function of the body of man or other
animals, and which does not achieve any of its primary intended purposes through
chemical action within or on the body of man or other animals and which is not
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dependent upon being metabolized for the achievement of any of its primary
intended purposes (FDA, 2010)."
4.3 The Comparison of Medical Device Definition
The definitions of Medical Devices in China and the US are similar, but still
have several differences, such as:
1. In China’s definition, it is seeing the medical used software as medical
devices, but the US doesn’t. The software does not mention in the definition
of medical devices, however, the US FDA has the “General Principles of
Software Validation,” and the software validation also administrates by the
Center for Devices and Radiological Health (CDRH). Therefore, this is just a
descriptive difference.
2. The US emphasizes that the devices are “recognized in the official National
Formulary, or the U.S. Pharmacopoeia, or any supplement to them.” The
FDA has a database which can check the classification of the medical devices,
whereas China has the “Product Classification Catalog of Medical Devices.”
3. The US contains the devices for “the other animals” as medical devices,
which China does not. China has a veterinary department the Ministry of
Agriculture administrates the veterinary devices. Thus, in China, medical
devices related to “the other animals” do not administrate by the SFDA; and
in the US, all medical devices administrate by the US FDA.
4. In the China’s definition, the devices related to controlling of conception are
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medical devices. In the US, there are no such words. Although I reviewed the
“Product Classification of Medical Devices,” I cannot find any devices
related to the control of conception.
5. The Comparison of Classifications of the Medical Device
5.1 The Classification of Medical Devices in China
The classification of medical devices in China divides by three risk levels from low to
high (Regulations, 2000).
Class I Medical Devices: safety and effectiveness can be ensured through routine
administration;
Class II Medical Devices: further control is required to ensure their safety and
effectiveness;
Class III Medical Devices: implanted into the human body, or used for life support or
sustenance, or pose potential risks to the human body and thus must be strictly
controlled in respect to safety and effectiveness.
5.2 The Classification of Medical Device in US
Class I: General Controls
Devices for which general controls are sufficient to ensure safety and effectiveness
Pose minimal harm to user.
Examples: bandages, examination gloves,
Class II: Performance Standards and Special controls
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General controls determined to be insufficient to provide reasonable assurance of
safety and effectiveness
However, there exists sufficient information to establish performance standard to
provide such assurance
Higher risk that class I
Examples: wheelchairs, infusion pumps, daily wear contact lenses, urological catheter,
condoms
Class III: Premarket Approval
Stringent regulatory class
Used for life-sustaining or life-supporting purposes, those implanted in the body and;
Those presenting potential unreasonable risks of illness or injury
These devices have insufficient information to provide reasonable assurance of safety
and effectiveness
Examples: overnight wear contact lenses, replacement heart valves, cardiac stents
(Part 860, 2010)
5.3 The Comparison of Classification of Medical Devices
The US FDA is the one who proposed to classify the medical devices in order to
improve the management effectiveness; The European Union and China have
followed and modified the pattern. The European Medical Devices Directive (MDD)
divides medical device products into 4 levels – I, IIa, IIb and III, as the US and China
have 3 levels. The Global Harmonization Task Force (GHTF), which is an unofficial
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international organization focus on achieving greater uniformity between national
medical device regulatory systems, considers the 4 level European classification is
more reasonable. The EU classification system is based on the principle of
classification; the US is based on the medical devices classification database, with the
experts support. Compare with EU and US, China uses the product classification
catalog of medical devices, similar as the US classification database, but also use the
principle of classification. Briefly, based on its unique status of the medical device
market, China learned from US and EU on the medical device classification.
Otherwise, the proportion of high-risk level medical devices is different in these three
systems. In EU and US, the medical devices divided into level III are much less than
the ones in China. Actually, too many products divided into level III will give the
manufacturers a heavy burden, and cause the low effectiveness on the governmental
administration.
6. The Differences of Medical Devices Administration System in China
and US
6.1 The Legal Status
In the United States, the medical device related laws were passed by the congress.
The current laws related to medical device include “Federal Food, Drug, and
Cosmetic Act (FD&CA)”, “Fair Packaging and Labeling Act”, “Medical Device
Regulation Act”, “Food and Drug Administration Modernization Act” and “Medical
Device User Fee and Modernization Act (MDUFMA).” All these laws were passed by
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the US congress. The Federal Food, Drug, and Cosmetic Act, as the basic law in
medical device regulation, has been modified many times, and has very detailed rules
for the specific medical devices, such as the definition on mislabeled or unqualified
medical devices. Other countries always use US standard as the reference standards.
The China’s “regulations on supervision and management to medical devices”
was promulgated by the State Council, so the legal status is not as high as the US
FD&CA. The detailed rules in China’s regulation are not so specific, because China
does not have so much experience as US does. Otherwise, there are some overlapped
responsibilities between the different departments.
6.2 The Administration Status
FDA is a federal agency, and it has district offices in more than hundred cities.
Compare with the FDA, SFDA has 2 levels, besides the national level, there is a
provincial level, which lead the city and country levels below. There are more than
hundred city level agencies and thousands country level agencies all over the nation.
The FDA model is more appropriate to implement the policies.
The administrational level differences are caused by the different political
systems. The United States is a federal country; every state has its own autonomous
rights. The federal government only controls inter-states and international business.
The federal government set the agency like FDA because the medical devices relates
to people’s health. It is serious, and need the communication between all the states, so
the states do not need to have their own state-level FDA, all in charge by FDA.
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Compare with the US, China is a centralized country, the city level agencies lead by
the provincial level and national level agencies at the same time. China built the
surveillance and communication network from nation level to city level, in order to
enhance the management of medical devices.
6.3 Opening Information
FDA is one of the most respected administrations in the US legal system,
although it has been doubted in recent years. According to the official survey, the
approval rate of FDA is higher than the federal government. Even after the Vioxx
event, the FDA planed to have some innovation. The way FDA can get support from
public is the scientific decision-making, information opening and propagandizing
widely. FDA not only has the experts to evaluate the advanced medical devices, but
also prefers to get feedback from the public and make improvement. This is the way
FDA keeps a good relationship with the public.
Compare with FDA, SFDA emphasizes the pre-market approval and supervision.
All the medical devices need to get the pre-market approval, and the manufacturer
who produce level II and III medical devices also need the certification. The transfer
to pay more attention on post-marketing supervision will spend a long time for SFDA.
6.4 Dealing With Adverse Events
FDA and SFA have different ways on dealing with adverse events. If the FDA
meets such problems, their main actions will be correction and punishment. The FDA
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encourages the manufacturers recalling the products, and sometimes the problem can
be solved by improve the product or correct the management on-site. Otherwise, the
FDA will release the warning letter to the public or the manufacturer. If the
manufacturer does not do anything, the FDA will enforce the punishment. SFDA has
the similar punishment policy as FDA, but it is has more freedom. In China’s medical
device regulation, there is specific punishment for the slightest illegal act, and there is
no policy about recalling and releasing a warning letter.
7. How to Improve the Chinese Medical Device Registration System.
7.1 Establish and Standardize the Nomenclature of Medical Devices
The naming of medical devices is a scientific nomenclature which should be
simple, practical, scientific and standard. The uniform of the medical device products’
name is directly connected with the uniform of medical devices market. All the
non-standard names, deceptive name and the name departure the legal advertising
regulations should be removed or corrected. Government should build a completed
system to standard the requirements of medical devices marketing, the testing
methods, and the guidelines for technical reviewing.
US FDA has already established a detailed naming system of medical devices. It
can also be used in China. But the most important thing now is to establish the
nomenclature for medical devices. In general, the name of medical devices is very
important as the basic theory and combined with functional objects, producing
purpose, forms and other elements.
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Standard name of medical devices should be regularly edited and announced in
public, then supervised by people and market.
7.2 Adjustment of the Product Classification.
The current category version of medical devices classification in China is too old
with unclear and unscientific standards. Different class of medical devices should
have different principles and different requirements followed with the general control,
special control and high-risk control.
Senior scientists reviewing or auditing review is necessary when it is unsure how
to make a product name. Classification should not proved only by a report from
manufacturer or a governor. Only the relevant departments of State Council on the
substantive reviewing and products evaluation can give the correct name.
7.3 Scientific Clinical Trails for Medical Devices
In Chinese pharmaceutical industry, not all the medical devices need to do the
clinical trail, some of which need to do the clinical trail even investigation after being
published, some of which only need to do the results comparison testing with another
similar functional equipment if the medical device is under a low management risk.
Different situation should be treated different.
Building the technical guidelines for different types of medical devices, different
type of clinical trails and clinical validations is the first important thing to do on
current situation to make clear requirements. The guideline should be built under the
17
control of government administration.
8. Challenges in Chinese Medical Devices Industry
8.1 Standards in different levels are different
In China, manufacturing and management standards always changed with the
development of technology, which makes a big challenge for companies and agents.
An application or manufacturing procedure used in one product can never be used in
another product. Governmental document said that “changes occur to the national
standards or industry standards for which the product standards are adopted, medical
devices which had received registration approval…should approved according to
original standards…however, the medical device should be manufactured according
to the new version”. It is unclear here that which version of standard we should follow,
the national standard, the industry standard or the product standard? And which
should be the original standard? Those confusing information also happened
frequently in all the related standards.
8.2 Laws and Regulations are Constantly Changing
Not only the standards, but also the laws and regulations are constantly changing.
Take the State Council Order 276 for example. Order 276 is regulation for the
supervision and administration of medical devices, governing China’s health sector. It
is enacted in April 1st, 2000 and has been amended on several occasions by “red
letters”, which is given legal effect. But until Sep. 6, 2010, Order 276 has been
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amended 6 times, expanded from 6 chapters, 48 articles to 9 chapters, 88 articles.
8.3 Limited Official Announcement in English
The SFDA website is using simple Chinese as the official language which is hard
for foreign companies to understand and follow. Chinese government updates latest
domestic news about the safety of food and drug, also the policies and rules
frequently through the State Food and Drug Administration on its website. But all the
information is written in Chinese. The English translated website of SFDA does not
include all the information from the original webpage and only updated monthly with
few news and regulation guidelines. Some translations of regulations provides in
“Chinglish” which means “Chinese English”. “Chinglish” can annoy readers, and
embarrass non-native English speakers and always make them misunderstand the real
meaning of Chinese regulations and policies.
8.4 Much more Complex Relationships between Chinese Industry and
Government
With the development of thousands of years, relationship becomes very
important in Chinese culture. The same in health industry, all the business man in
medical device field have to learn the relationship between human beings, the
relationship between government and industry, the relationship between consumers
and producers. The manufacturer has to be aware of consumers’ needs and will take
them into account when deciding the course of the future actions which concern or
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could concern themselves without any specific discussion or request. The
manufacturer should also consider about how to build a good relationship with
government and public, which is a big challenge for those who are not really familiar
with Chinese culture and custom.
9. Opportunities in Chinese Medical Devices Industry
April 6, 2009. Chinese government announced a new reform scheme on medical
and health system. About RMB 850 billion (about 127 billion dollars) will be invested
through 2009- 2011 to promote medical and health system reform, which is a good
news for both domestic and international medical device manufacturers. Expert in
related field estimated that at least RMB 16 billion will be used in Medical Device
investment. This is a big opportunity for those competitive companies which want to
expand capital in international market to fight for the benefits from this reform.
For those developed countries, they have competitive advantages to develop the
most advanced technologies or import new products to Chinese market. In China, they
don’t have any domestic medical device companies with the capital of more than 5
hundred billion dollars. The only few competitive companies are those international
Joint-stock cooperative enterprises or international investment company. But in the
world, it has more than 300 hundred companies in health field with the capital of
more than 5 hundred billion dollars. America takes 170 of them.
10. Conclusion
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After comparing the medical device regulation difference in US and China and
analyzing the challenges in Chinese industry, we can find out that Chinese
government has paid more attention to promote the development of medical device
industry. With the improvement of related polices and regulations, Chinese will
become a large market to provide more opportunities to medical device manufacturers
and perfect its health system.
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23, 2010.
22
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