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Medical Devices China

I am an expatriate Medical Device Consultant living in Shanghai servicing importers to Mainland China. My focus is international small to medium sized manufacturers who need to find reliable and trustworthy partners in this exciting market. My involvement in China began over 10 years ago, and I have assisted and negotiated on the behalf of many companies in a variety of fields: Orthopedic, Cardiology, Opthamology, emerging Vascular Closure and Hemostatic technologies. The first obstacle upon a entry for most manufacturers is finding a reliable partner and any company who does a little research will discover a myriad of "horror" stories. From failed Joint ventures to fraud, dishonesty and mis-communication it's endless. The market is undergoing changes however, and a few savvy Chinese operations are seeing the opportunities for long-term collaboration and providing first class international networks. Inclusion in the WTO and the rapid pace of change nationally and within the medical field specifically are further contributing to better standards. The initial phase of locating the distributor that best fits your product is an area of the highest priority and an understanding of first how this market works is pivotal to success. SFDA approvals are necessary for Medical device sales and this is also an area where the correct connections can see rapid approval. Generally with the correct strategies approvals can be obtained in less than 9 months as opposed to the 2-3 year delays incurred by an inexperienced attempts. Further details for gaining product approval for China (SFDA) at http://www.cmdi.gov.cn/. Further postings will address in more depth my own experiences and market changes in an ongoing effort to keep those interested of market and legislative changes in the P.R.C.

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