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Selling Medical Devices in China A Market and Regulatory Update

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.. Nypro's Mission Statement . Diversification Through Market Segmentation Worldwide Sales by Industry - FY04. Typical Healthcare Projects.

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Selling Medical Devices in China A Market and Regulatory Update

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    1. Selling Medical Devices in China – A Market and Regulatory Update

    2. Nypro’s Mission Statement

    3. We plan to double this business by 2009. We plan to double this business by 2009.

    4. Typical Healthcare Projects

    6. Nypro’s Global Footprint

    7. Nypro’s 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 1992 Microplas Nypro SingaporeMold In 1979, Nypro started in China with an alliance with an existing molder to make plastic tags. In 1979, Nypro started in China with an alliance with an existing molder to make plastic tags.

    8. China is 21% of Nypro’s revenue, employs half of its employees (7,500) and contributes significantly more than profit than their percentage of sales. Nypro is opening one new plant with 600 people every quarter. China is 21% of Nypro’s revenue, employs half of its employees (7,500) and contributes significantly more than profit than their percentage of sales. Nypro is opening one new plant with 600 people every quarter.

    9. 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

    10. 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 The Chinese SDA is equivalent to the US’s FDA. The China Association of Medical Devices Industry is providing guidance for the Chinese cGMPs. Certain classes of medical devices are not allowed to be reused. The Chinese SDA is equivalent to the US’s FDA. The China Association of Medical Devices Industry is providing guidance for the Chinese cGMPs. Certain classes of medical devices are not allowed to be reused.

    11. 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 A typical pallet of product is 40”X48”X60” weighing approx. 118kgs with dimensional volume of 315kgs. Air freight is $4.04/kg =$1,272.60 /pallet and takes 3-5 days in transit. Ocean freight is $350/pallet for a 20’ container and $225/pallet for a 40’ container and takes 30-45 days. A typical pallet of product is 40”X48”X60” weighing approx. 118kgs with dimensional volume of 315kgs. Air freight is $4.04/kg =$1,272.60 /pallet and takes 3-5 days in transit. Ocean freight is $350/pallet for a 20’ container and $225/pallet for a 40’ container and takes 30-45 days.

    12. 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. Although there are laws in place to control labor, the environment and IP they lack systems to enforce them.Although there are laws in place to control labor, the environment and IP they lack systems to enforce them.

    13. Chinese Proverbs

    14. I will leave you with one last Chinese proverb “ No one can be a great man until he goes to The Great Wall” I will leave you with one last Chinese proverb “ No one can be a great man until he goes to The Great Wall”

    15. However I can tell you from personal experience, the chances of that one coming true are questionable. However I can tell you from personal experience, the chances of that one coming true are questionable.

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