Washington, D.C. -- China's State Food and Administration (SFDA), a parallel organization to our own FDA, has requested that the U.S. Department of Commerce form an industry roundtable to assess how refurbishing is now handled and regulated in America. The members of this group will also form a delegation that will go to Beijing at the end of August for joint talks with Chinese on this issue.

IAMERS plans to participate in this roundtable according to its Newsletter.

The SFDA has released its initial draft of a 33-article document entitled "Rules for The Supervision and Administration of Refurbished Medical Devices for Re-Use." This is the heart of the regulatory guidelines under review. DOTmed believes it may be possible for interested parties to get a copy of this through The U.S. Commerce Department.
Currently, before any medical equipment can enter China, the exporter must get authorization from the Chinese Department of Medical Devices Administration.

Obviously, the results of this review will impact the business of selling used medical equipment to this huge market for years to come. DOTmed will follow this story closely and will report on any developments. We invite our readers who have any information on this issue to submit it.

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