Report Cites Barriers for Medtech Firms Seeking Access to Japanese Market 4728

April 1, 2007

3 Min Read
Report Cites Barriers for Medtech Firms Seeking Access to Japanese Market

Onerous compliance procedures, associated delays, and increased costs are having a chilling effect on the number of U.S. companies submitting products for review to the agency responsible for approval of pharmaceuticals and medical devices in Japan.

According to a report prepared by the United States International Trade Commission (ITC; Washington, DC), the average time for getting new medical devices approved in Japan in 2004 was significantly longer than in other markets. The report notes that the average approval time for a new medical device in Japan that year was 1083 days, compared to 356 in the United States.

According to the ITC report, new device applications submitted by U.S. companies for review by Japanese regulators dropped precipitously from 132 in 2003 to only 8 in 2005—a 94% decline. Representatives of the U.S. medtech industry cited "burdensome applications and an unpredictable approval process" as reasons for the decline.

The study notes that although the Japanese approval process does not discriminate against applications from foreign firms, the regulations and procedures are more complex and time consuming for advanced high-technology products. Because U.S. medical device firms are the leading developers and exporters of such products, says the report, they may be disproportionately affected.

Overall, the report calls Japan's approval process the "slowest, least transparent, and most difficult regulatory system" of the world's major medical device markets.

In 2002, responding to pressure from both domestic and international sources, Japan began efforts to modify its Pharmaceutical Affairs Law, which includes the nation's medical device regulatory approval system. Similar to past regulatory reform in the United States, the primary goals of the Japanese initiative were to improve efficiency and shorten product approval times. The ITC report cites some limited success in reducing product approval times following enactment of the new law in 2005. However, the report concluded that significant challenges remain.

The report cites three types of unique costs associated with getting a medical device approved for the market in Japan: opportunity costs associated with much longer product approval times, costs associated with the requirement to conduct additional clinical trials to satisfy Japanese regulators; and costs associated with regulations requiring firms to separate their marketing and safety operations from production functions. U.S. industry officials estimate that complying with recent changes in Japan's regulatory system has already cost American companies $350 million and will result in an additional $1.2 billion in compliance costs over the next five years.

According to the report, there are two major factors contributing to the longer medical device approval times in Japan: too few experienced reviewers to handle approval applications, and a backlog of applications from the previous system. With only 28 evaluators, the Japanese regulatory staffing level is well below that of the United States.

Just days after ITC released its report, Boston Scientific Corp. (Natick, MA) announced that its Taxus drug-eluting coronary stent had been approved for the Japanese market—more than three years after gaining FDA approval.

"The ITC report lays out the key problems and difficulties U.S. medical device manufacturers face in getting their products approved for the Japanese market," says Philip Agress, vice president for global strategies and analysis at industry association AdvaMed (Washington, DC). "Japan is well aware of the problems—and has been for years. The delays in getting products approved not only adversely affect market access for U.S. manufacturers, but also prevent Japanese patients from gaining access to beneficial healthcare technologies."

AdvaMed has been a longtime advocate for streamlining the Japanese medical device approval process.

The Medical Device Manufacturers Association (MDMA; Washington, DC) said that the 2005 changes in Japan's Pharmaceutical Affairs Law have created numerous barriers for the industry. Both AdvaMed and MDMA said they will continue to work with Japanese authorities to facilitate better access to the country's medical device market.

ITC's detailed 180-page report, Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets , can be downloaded at

© 2007 Canon Communications LLC

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