DRW Monthly
January 2009
Issue No. 26

Japanese Government Adopts Medical Device Approval Action Program

The Japanese government approved a fiscal 2008 economy stimulus package last June that included a plan to accelerate the approval of Japanese-manufactured and imported pharmaceutical and medical device products, and to provide increased federal support for developing innovative technologies. To carry out this plan, the government appointed the Japanese Ministry of Health, Labor and Welfare (MHLW), the Ministry of Economy Trade and Industry, along with other ministries and related industries to develop an action program this past fall in order to reduce and ultimately eliminate the medical device approval lag.(1)

The government subsequently approved the MHLW's five-year action program in December. Key features of the program consist of:

• streamlined review processes through improvements to partial change, stability testing and clinical requirements;
  
• establishment of a three track review process: one for completely new products, one for improved products, and one for "me-too" products;
  
• an increased number of medical device reviewers from 35 to 104 over the next five years;
  
• extensive training for reviewers so they can meet new performance goals; and,
• objective performance measures to be used to evaluate the reviewers semi-annually.(2)
  

In order to implement these ambitious five-year goals, effective April 1, the government will be increasing user fees from the current levels by a factor of 1.2 to 2.8, depending on the product category. The largest fee increase will impact new medical devices in the country's Class IV highest risk category.(3)

The Japanese medical device market, although potentially a wealth of opportunity for foreign medical technology manufacturers, has historically proven to be extremely cumbersome and frustrating to navigate. Despite the MHLW's creation of the Pharmaceutical and Medical Device Agency (PMDA) branch within the agency, and its enactment of the Pharmaceutical Affairs Law (PAL), the 2005 decree governing medical device approval, firms have continued to face considerable hurdles during the device approval process. The PAL amendments to Japan's medical product laws instituted new clinical trial import requirements, implemented good manufacturing practices which require foreign manufacturing quality management systems (QMS) to meet Japanese QMS standards, and introduced post-marketing surveillance requirements.

For this reason, it is not without a small amount of skepticism that industry is evaluating Japan's proposed regulatory developments. The biggest obstacle between industry and Japanese regulators has centered on cases in which companies want to make relatively minor changes to a device or its labeling. Regulators have historically insisted on a complete review process regardless of how insignificant the request, e.g., a facility address change. Although the new action program asserts that partial device changes will now be assessed according to risk, companies will still have to consult reviewers, on a case-by-case basis, for each proposed modification. In addition, beginning in April, all low-risk Class II products will be allowed to receive approval via a third party, whereas only a portion of these products were permitted to go through the third-party process under the current regulation.

Japan's Action Program is unquestionably an encouraging development for foreign manufacturers planning to launch a new device in the country's improved medical device regulatory environment. The program's goals more closely align Japan's regulatory program with US and EU medical device approval procedures and review schedules. The hope is that these changes are just the beginning of the country's reform process and that it will continue to streamline and harmonize all of its regulatory practices to comply with existing global device regulatory programs.

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