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About Lee Leichter
Expertise
Manufacturing, Outsourcing, Regulatory (FDA), Quality systems and problems, Exporting, Start-up Issues, strategic planning, Distribution, etc.

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Employment history: Over 25 years in the industry

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You are here:  Experts > Health/Fitness > Pharmacology > Medical Supplies & Devices > Export US made medical devices

Medical Supplies & Devices - Export US made medical devices


Expert: Lee Leichter - 8/13/2006

Question
Hi Lee,

This is Tony and I have a small firm in San Francisco. I have very good connections with some big hospitals and pharmaceutical distributors in China. They asked to find some medical device manufacturers and new drugs in US and export to China market. Right now, 40% of China¡¯s medical import is from US and I feel it is a good opportunity to boost my business.

My question is that how I can find this kind of suppliers (I am not from medical background and do not know too many persons from this field).

My ideal targets for both device and drug companies are:
Small to mid size company
Have unique products in the world
Have no ability to set up a team in China

I can give you some example that my friends asking: such as recombined human albumin (China has long history of contaminated blood source, they rather believe imported blood products)

I was wondering if you could give me some thoughts on this.

Thank a lot.

Tony

Answer
Hi Tony,

This sounds like a pretty good opportunity.  There are some hurdles.

The first is whether the product is legally approved for sale in China by the CFDA (Chinese FDA).  Just because it is available here does not mean it is approved for import into China.  If you want to gain approval, you may need information from the company.  If they have taken steps to gain approval, they would likely already have an agent of distrubutor.

If you are willing to take on the regultory hurdles, finding the companies is simply a matter of identfying the product and then looking on the FDA website to see who has an approved or cleared product.  Most would be delighted to have someone get them into that market.

Feel free to give me a call at 239-994-6488 to discuss.

Lee  

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