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Quality Digest

FDA Compliance

TÜV America Offers Certification Services to New Japanese Pharmaceutical Affairs Law

Published: Tuesday, September 27, 2005 - 22:00

TÜV America recently announced its ability to offer medical device certifications to the new Japanese Pharmaceutical Affairs Law (PAL). Effective since April 1, PAL monitors how medical devices are marketed and regulated in Japan. It regulates and classifies medical devices by their level of risk. It also affects in vitro diagnostics reagents, medicines, toiletry products and cosmetics. The certifications will be offered by TÜV Japan Ltd., which is a subsidiary of TÜV SÜD Group, as is TÜV America. TÜV Japan Ltd. is accredited to assess all categories and in vitro diagnostic reagents.

“As a former Japanese In-Country CareTaker, TÜV has the experience and knowledge to help customers navigate through Japan’s unique requirements,” says John Bier, TÜV America medical products director. “Our auditors have passed a stringent PAL training program and qualifying exams that allow us to perform a single, comprehensive audit which can result in multiple regulatory certifications for our clients.”

TÜV America will also host a series of Webinars discussing the PAL. The Webinars will provide clients with an overview of the system, licensing requirements, QMS requirements, reporting requirements and more. It will be offered Oct. 21, Oct. 25 and Oct. 26.

TÜV America is a testing/certification organization that provides CE marking assistance, mechanical/electrical product safety, electromagnetic compatibility (EMC), field evaluations, NRTL and SCC certification. For more information, visit www.tuvamerica.com.


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