AdvaMed Asks Japan for Quicker Approvals

Representatives from AdvaMed met with senior Japanese Officials to discuss expediting the country's approval process for medical devices. Advamed's chair, James V. Mazzo, and CEO, Stephen J. Ubl, encouraged the leaders to bring policy into alignment with the government's “New Vision for the Medical Device and Medical Technology Industry,” which supports a vibrant domestic medical technology industry.

November 11, 2010

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“Japan is AdvaMed member companies’ largest market outside the U.S., but we are very concerned about policies that inhibit innovation in the medical technology industry for both U.S. and Japanese firms,” Mazzo said in a press release. “U.S. firms make a substantial contribution to Japan’s economy, employing more than 13,000 people, and some are considering whether they can afford to remain in Japan. In the end, it is Japanese patients who suffer when they cannot receive the most advanced therapies available.”

Read more about the challenges of marketing medical devices in Japan: Q&A with Kazuo Ogino, chair of the Japan Federation of Medical Device Associations.

Mazzo and Ubl met with members of the Japanese Diet. They also met with Seiji Maehara, the Minister of Foreign Affairs; Yoko Komiyama, Senior Vice Minister of Health and Welfare; and Tatsuya Kondo, Chief Executive of the Pharmaceuticals and Medical Devices Agency, among other officials involved with regulatory policies related to medical devices.

Heather Thompson

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