FDAnews Device Daily Bulletin

JAPAN VOWS TO SPEED DEVICE APPROVALS

Nov. 7, 2005
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Japan has vowed to accelerate regulatory reforms that will speed the introduction of safe, effective and innovative medical devices to Japanese consumers, according to a new joint U.S.-Japan government trade report on regulatory reform and competition policy.

The Japanese Ministry of Health, Labor and Welfare (MHLW) is striving to achieve expeditious reviews and approvals of medical devices, said the report, presented recently to President Bush and Japanese Prime Minister Koizumi.

MHLW recognizes the substantial backlog of medical device applications pending at the Pharmaceuticals and Medical Devices Agency (PMDA), which was established in April 2004. MHLW will "strongly encourage PMDA to work as quickly as possible to eliminate the backlog," the document says. "At the same time, MHLW will ensure that PMDA will process new applications within the timelines designated in PMDA's performance goals."

Starting in fiscal 2005, MHLW also plans to accept clinical data obtained outside of Japan for medical devices in Japan, as long as the applicant proposing a device shows that the data comply with good clinical practices that are regarded as substantially equivalent to Japan's good clinical practice standards.

AdvaMed praised the Bush Administration for securing commitments from Japan to improve its regulatory process for medical devices. The goal is to create a speedier and more transparent regulatory process, which promotes faster introduction of new technologies, increased consumer choice, and expanded access for U.S. companies in the Japanese market, AdvaMed said.