Axiom Worldwide Brings Home Another Win For The U.S. In China By Receiving SFDA Certification For The DRX9000™!

TAMPA, Fla.--(BUSINESS WIRE)--On July 11, 2008 Axiom Worldwide received the SFDA (State Food and Drug Administration) Registration Certificate in China for the DRX9000™. SFDA, the Chinese equivalent of the US Food and Drug Administration (FDA), is making greater efforts to create a better medical device regulatory environment.

In August 2004, the SFDA implemented new registration requirements for medical device applications and the review process. The new regulations have combined the dossier preparation and specification application into one step. Companies no longer apply to the SFDA for specification validation. Instead, they use their own specifications as a basis for a testing agency to provide testing. Companies then include these test results in the completed dossier and submit it to the SFDA who then sends this dossier to the Medical Device Evaluation Center (MDEC) to review the specifications, dossier, government certificate and clinical report. The MDEC sends their conclusion to the SFDA and upon acceptance the SFDA will issue the import license. While these new regulations have somewhat streamlined the process, they have not significantly altered the timeframe for medical device registration in China. Prior to registration in China, devices manufactured in the Unites States must be cleared for sale in the United States by the U.S. Food and Drug Administration (FDA) and the FDA Certificate to Foreign Government must be submitted with the registration application.

China has very specific policies in place to ensure that all medical devices sold there are safe and effective. Axiom Worldwide has met the very demanding requirements to achieve this certification. Axiom is committed to manufacturing quality non-surgical products that are safe and effective for treating chronic back pain patients worldwide.

Axiom Worldwide manufactures and distributes its flagship products, the DRX9000 True Non-surgical Spinal Decompression System™, DRX9000C™, and DRX9500™ in medical markets around the globe. Axiom also manufactures a digital electroceutical device, the EPS8000™, for use in relieving pain and for use in muscular rehabilitation. Axiom prides itself on providing safe, non-surgical alternatives that patients should consider prior to undergoing surgery. For additional information please visit: www.AxiomWorldwide.com. To schedule an interview please contact: Amber Pacetti, Marketing at: telephone: 001-813-249-6444 or email: apacetti@axiomworldwide.com.

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