Selling Medical Devices in China A Market and Regulatory Update

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Selling Medical Devices in China A Market and
Regulatory Update
Nypros Experience as an OEM Supplier Presented
by Bill Partridge Healthcare Business Unit
Manager
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Nypros Mission Statement
To be the best in the world at providing
integrated and innovative plastic solutions, from
design to delivery, creating value for our
customers employees and communities.
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Diversification Through Market SegmentationWorldw
ide Sales by Industry - FY04
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Typical Healthcare Projects
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Our Customers
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Nypros Global Footprint
Asia/Pacific Guangzhou, China Shenzhen,
China Suzhou, China Tianjin, China Bangalore,
India Jurong, Singapore
North America Dothan, AL San Diego, CA Marietta,
GA Mt. Pleasant, IA Gurnee, IL Louisville,
KY Clinton, MA Burlington, NC Asheville,
NC Corvallis, OR El Paso, TX
Europe Chartres, France Tata, Hungary Nagyigmand,
Hungary Bray, Ireland Moscow, Russia Wrexham,
Wales
Latin America Manaus, Brazil Santo Dominigo,
DR Chihuahua, Mexico Guadalajara,
Mexico Monterrey, Mexico Cayey, Puerto
Rico Aguadilla, Puerto Rico
Healthcare facilities in black
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Nypros 25 Year History in China

• 1955 Nylon Products founded
• 1971 Automated Assemblies Corp.
• 1972 Bigelow Carpet Mill purchased
• 1973 Nypro Puerto Rico
• 1977 Company name changed to Nypro, Inc.
• 1979 Nypro Hong Kong Trading
• 1980 N.P. Medical
• Nypro Ireland
• 1981 Nypro Atlanta
• 1982 Nypro Chen (Hong Kong)
• 1987 Nypro Carolina
• Nypro Singapore
• Nypro Advanced Technology Center
• 1988 Nypro San Diego
• NyproMold
• Nypro Asheville
• 1989 Nypro Iowa
• 1990 Nypro Moscow
• 1991 Nypro Georgia

1993 Nypro Chicago Nypro Shenzhen (China) Nypro
Precision Assemblies 1994 Nypro Wrexham Nypro
Oregon NyproMold Chicago 1995 Nypro
Colorado Nypro Alabama 1996 Nypro
Bangalore Nypro Tianjin (China) 1997 Nypro
Kentucky Nypro El Paso Nypro Germany 1998 Nypro
Dominican Republic Nypro Tool Hong
Kong 1999 Microplas name changed to Radius
Product Development 2000 Nypro Monterrey 2001
Nypro Guangzhou (China) Nypro Suzhou
(China) 2002 Nypro Guadalajara Nypro Tool Suzhou
(China) Nypro Tsuda Surface Technology (China)
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Global Sales Diversification Worldwide Sales by
Region - FY04
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Chinese Healthcare Market

• 7 Billion Medical Manufacturing Industry
• Producing 45 of current needs 55 imports
• 15/yr. growth 2x worldwide average
• 1.3 Billion people
• 300M baby boomers
• 300K healthcare facilities
• Booming economy, rapidly expanding middle class
  demanding more sophisticated healthcare

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Doing Business in China

• WTO encourages medical mfg. investments w/tax
  incentives, fewer barriers IP risk, foreign
  companies can own distribution channels
• WTO drives private foreign investment in
  hospitals
• China SDA prohibits re-use of disposable medical
  devices
• China Association of Medical Devices Industry
  formed new Chinese cGMPs

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Issues to Consider

• Is your product for Chinese distribution or
  export?
• What is the equipment vs. labor content?
• VAT on imported equipment (new)
• 1/10th labor cost
• Exported product has logistics cost
• VAT on product WTO lowering tariffs
• Shipping - boat vs. plane
• Cost of WIP 1-2 months

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Issues to Consider

• Labor Law Compliance
• Environmental Protection
• Intellectual Property Protection
• Laws can be drafted and implemented quickly and
  unexpectedly
• New China cGMP requirements
• Availability of financials for state/private co.

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Chinese Proverbs
Dig a well before you are thirsty
Do not fear going forward slowly fear only to
stand still
Deep doubts, deep wisdom, small doubts, little
wisdom
He who asks is a fool for five minutes, but he
who does not ask is a fool forever
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