For many years, there has been strong criticism by the United States and European countries that market authorization for introducing advanced medical devices in Japan has been slow. In many issues of MPO, this column has addressed the steps that multiple stakeholders inside and outside of Japan have taken to address this so-called “device lag.”

Over the years, it has become a serious diplomatic issue among leading countries that produce cutting-edge medical technology and then look for international markets. The medical device industry isn’t alone, however.

This phenomenon also is at work with pharmaceutical products too, as many new drugs, such as cancer therapies, are not approved in Japan.

The lag in both sectors has been criticized not only by authorities such as the U.S. Food and Drug Administration (FDA), Congress and U.S. industry trade groups, but also by patients and medical professionals in Japan.

As patients and healthcare providers quickly learn what’s available in other countries (thanks mostly to the Internet), their frustrations grow.

Japan’s Ministry of Health, Labor & Welfare (MHLW) and the country’s evaluation agency, the Pharmaceuticals & Medical Devices Agency (PMDA), have been engaged in efforts through diplomatic channels such as the Global Harmonization Task Force (conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems including the United States, the European Union, Canada, Australia and Japan) and Harmonization By Doing (a bilateral effort between the United States and Japan). Tangible improvement, however, has not been accomplished so far, according to most industry experts.

In the recent past, the MHLW and PMDA have introduced many administrative measures, including: major reform of Pharmaceutical Affairs Law in 2005; introduction of third-party evaluation for standardized Class II devices; rapid introduction of prioritized, high-need medical devices; increasing the number of device reviewers; expanding consulting services to enhance earlier applications; and introduction of a three-track evaluation system (“me-too” devices, improved products and new concepts). The changes have been incremental, but no major improvements have been made so far.

Results of recent studies conducted by the medical device subcommittee of American Chambers of Commerce of Japan, which recently was reorganized as the American Medical Device & Diagnostics Manufacturing Association, show interesting results.

The association examined device approvals from April 2003 to March 2006 and then again from April 2005 to March 2008. The group then compared both sets of results. For the first time period, pre-market approval-equivalent medical devices took, on average, 26.6 months to receive approval, while the average time during the second surveillance period has shortened to 21.1 months.

For 510(k)-equivalent medical devices, the evaluation period was significantly shorter—from 21.6 months to 12.1 mon-ths. The results certainly are a good sign that evaluation times have improved; however, in comparison to the FDA, the differences in approval times remain significant. For example, the FDA is able to approve certain PMA medical devices in as few as 10 months and 510(k) devices in two months.

Such significant efforts to shorten the evaluation period are appreciated; however, the new regulations require device manufacturers to take more time for the preparation of submission materials, and, as a result, the overall regulatory process has not been shortened. This is among the reasons why the device lag hasn’t yet been solved. Industry hopes that the five-year improvement plan discussed in the last installment of this column will have a more significant, longer-term impact and that further deregulation will result in a shorter application and approval process.

Yoshio Mitsumori is the president and CEO for Tokyo-based ADMIS, a consultant specializing in the medical device industry. He has more than 25 years of experience in the medical industry, including positions with the Itochu Corp., U.S. Surgical, National Medical Enterprises and Century Medical. A member of RAPS, he has spoken at many industry events and worked extensively in international trade of medical products and technologies. He can be reached at [email protected].