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.”

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