China Medical Device Industry
Wenqin Shao
Sino Waypoint Consulting Inc.
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China Market Overview
• China is a market unlike any others
• Second largest economy in the world
• GDP of over USD 6.9 trillion in 2007
• GDP has grow on average 9.9% per year
• Per capita income has grown at average
8%
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China Key Market Zones
1.Bohai Bay Loop (Beijing, Tianjing, and
northeastern areas)
2.Yangtze River Delta (Shanghai, JiangSu,
ZheJinag)
3.Pearl River Delta (GuangZhou)
• 100 cities with 1 million people or more
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Medical Device Industry
• One of the fastest growing markets
• Market size: USD $12.96 billion in 2006
• 12,000 Medical devices manufactures
• 62% private, 37% JVs and 1% SOEs
• Industrial output value above USD $5.75
billion in 2006 with growth rate at
27.44%
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2006 Trade Figures
Import value
Export Value
USD 3.7 billion
1.6 million
USD 6.9 billion
175,000
Domestic hospital
and Clinics
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2006
trade figures
Registered doctors
and surgeons
145,000
Distributors and
agencies
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Market Entry
 Comply with regulation and laws
imposed by the following
administrations
1. State Food and Drug
Administration (SFDA)
2. State General
Administration of Quality
Supervision
3. Inspection and Quarantine
of the People’s Republic of
China
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China IVD Market
• 6th largest market in the world
• Estimated at USD 1.5 billion growth at 30%
• 13,000 automated Labs and 5,000 semiauto
Labs, projected growth at 15% per
year
• 200 IVD product manufacturers provide
60% of domestic market needs
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Market Growth Factors
• Hospital system reform and Increased
availability of healthcare insurance
• Increased consumer power and equipment
purchase by hospitals and clinics
• Increased desire for utilization of advance
technology
• Growth desire for better quality of care
• Revised regulations on medical devices
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Product Registration
Class I:
Class II:
Devices
whose safety
and
effectiveness
can be
ensured
through
routine
administratio
n, they don’t
need to do
the Type
Testing in
China
Devices
whose
further
control is
required to
ensure their
safety and
effectiveness
, need to go
through the
Type Testing
in China
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Class III:
Devices which
are implanted
into the human
body or used for
life support or
sustenance or
pose potential
risk to the
human body,
must be strictly
controlled in
respect to safety
and
effectiveness
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Product Registration
• Product registration is
required by the State Food
and Drug Administration
• Product registration is
required for all import
Medical Devices from Class
II and III
• Product registration has 4
year validity and reregistration is required after
expiry
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Product Registration
Registered in China (2000 -2006)
Imported,
12,156
Total 55,643
 Domestic: 43,487
 Imported: 12,156
 Class I & II: 35,559
 Class III: 20,084
In 2006-11,724 Certificates
 Class I: 3,170
 Class II: 5,239
 Class III: 1,231
 Imported:2,045
Domestic
, 43,487
40,000
35,559
35,000
30,000
25,000
20,084
20,000
15,000
10,000
5,000
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Class I & II
Class III
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Intellectual Property Right
• China fully accessed to WTO’s
membership requirements in 2007
• Under IP laws and regulations fully alighed
with trade Related Intellectual Property
Treaties
• China has signed most of the international
treaties and conventions on IP protection
• China is member of the world intellectual
property Organization
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Intellectual Property Right
• Trade marks should be filed with the China
trademark Office
• Copyrighted works do not require
registration for protection, however you may
wish to register with China national
copyright administration on a voluntary
basis
• Unfair competition falls under the
responsibility of the Fair Trade Bureau under
the State Administration for Industry and
Commerce
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Intellectual Property Right
• China’s Legal System actively process
infringement laws suits
• There were 37,499 cases relating to
trademark irregularities that were processed
• China is the third largest country in terms of
the number of IPR infringement cases filed
in 2007
• 5,745 tons of pirated commodities
(estimated at RMB 242 million) were
destroyed
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China International Medical
Equipment Fair
China’s largest
M. D. Event
Gather leading M.D.
player from China
and world
Bring business
experience in China
Gather
Key Opinion
Leaders
Gateway for
Foreign M.D. to
enter China
Twice a year
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Contact Information
Wenqin Shao
613-761-8118
Wenqin_shao@siwyc.com
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