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ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Medical Device and IVD Compliance in Japan, China and South Korea
Bryan Gilburg Vice President of Business Development EMERGO GROUP bg@emergogroup.com
South Korea
Japan
China
The real list
Prioritize based on market potential (sales) vs. cost and time to access (regulatory)
• UN recognizes 38 countries in Asia, only 15 regulate devices • Populations range from China with 1.35 billion to Nauru with 9,500 • Markets with the most potential also tend to be regulated • Time and investment to access varies widely
Korea
Japan
Why export to Japan?
• Population of 127 million, 3rd largest economy
• Socialized healthcare system
• Japan’s device market expected to reach $39 billion by 2015
• Solid domestic device market, but also huge importer
• Daimyo system
• Complex, expensive distribution system
• Relationship based sales
Sources: Japan External Trade Organization, Japan Ministry of Health, Labor and Welfare
Japan population is declining but demand for
medical devices will grow because the median age is rising quickly, and
older people utilize healthcare more
intensively.
The Japanese regulatory process
START
South Korea
Medical Device Registration in Korea
South Korean Market Appeal
• Population of 50 million, growing but graying
• 15th largest global economy, about the same as Mexico
• Medical device market totals $5.1 billion*
• Expected to grow at 12-13% annually through 2018
• Domestic production strong in ultrasound, dental, therapy apparatus and consumables
• Aging population and economic growth will result in demands for better healthcare
• KORUS may boost US device exports
South Korea is moving to bolster
its domestic device industry to
diversify from consumer
electronics and semiconductors.
Domestic production is
around $4 billion*
* Source: Espicom
Medical Device Registration in Korea
Korean Market Characteristics
• Large, dynamic economy and medical device market
• Rapid adoption of new technology
• Large target universe
• Relationship-based sales
• Socialized healthcare system
• Heavy regulatory requirements
• Difficult to get information
China
Medical Device Registration in Korea
China Market Appeal
• Huge potential. 1.35 billion population
• Second largest economy; will likely surpass US in 10-12 years
• Fourth largest device market ($17 billion) behind US, Japan and Germany. Growing at 24%/year
• Enormous growth in healthcare spending over last 10 years
• Government investing heavily in healthcare delivery infrastructure
• Imports (perhaps surprisingly) are 73% of market.* Western brands highly respected!
Companies need to have good IP
protection in place.
Don’t try to export consumables, therapeutic
appliances or medical furniture or other low risk devices to China.
* Source: Espicom
Questions? Email bg@emergogroup.com
AMERICAS
ARGENTINA | Buenos Aires
BRAZIL | Brasilia
CANADA | Vancouver & Toronto
COLOMBIA | Bogota
COSTA RICA | San Jose
MEXICO | Mexico City
UNITED STATES | Austin
EUROPE/MIDDLE EAST
EGYPT | Cairo
FRANCE | Paris
GERMANY | Hamburg
ISRAEL | Haifa
NETHERLANDS | The Hague
RUSSIA | Moscow
SAUDI ARABIA | Riyadh
TURKEY | Istanbul
UNITED KINGDOM | Sheffield
Global Medical Device Consulting
ASIA PACIFIC
AUSTRALIA | Sydney
CHINA | Beijing & Hong Kong
INDIA | Delhi & Secunderabad
JAPAN | Tokyo & Kobe
MALAYSIA | Kuala Lumpur
NEW ZEALAND | Auckland
SINGAPORE | Singapore
SOUTH KOREA | Seoul
TAIWAN | Taipei
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