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

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Global Medical Device Consulting

ASIA PACIFIC

AUSTRALIA | Sydney

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JAPAN | Tokyo & Kobe

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NEW ZEALAND | Auckland

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