As this column has reported in previous issues of Medical Product Outsourcing, Japan’s regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), kicked off its five-year improvement program on April 1. The program was put together based on a government action program approved in June of last year for quicker, more aggressive approval of medical devices. When the program was formed last year, PMDA met with industry representatives. At this meeting, Tatsuya Kondo, M.D., Ph.D., chief executive of PMDA, outlined initial, basic policies to improve agency performance:

•  A five-year strategic management plan

• Increased fees from device firms for product safety enforcement and control of potential health hazards. The fee depends on a company’s annual sales.

• Reinforcement of evaluation capabilities and post-marketing surveillance

• Strategic collaboration with academia by which post-graduate students experience the clinical trials and evaluations at PMDA. This program will accept medical graduate students as reviewers of new drug or medical device applications, so that they can work on a thesis for an academic degree.

• Improvement of international collaboration. Through this program, PMDA will attempt to strengthen cooperation with other Asian countries, the European Union and the United States. The agency also will take part in international harmonization activities.

The medical device industry continually has expressed its concern that the agency was slow to respond to device approvals and did not have the resources it needed to manage its volume in a timely fashion.

Criticisms have included that:

• PDMA has been too slow to initiate actual evaluation (for example, orthopedic implants take eight months on average before a review takes place). Even standardized medical devices take too much time to review, and non-standardized products are much worse.

• Many queries raised by PMDA do not coincide with the guidelines set forth by the country’s ministry of health.

• Evaluations can be slowed or even reset due to a change of the reviewerin charge.

• Basic skills and/or knowledge about particular medical devices by specialtyoften are lacking to cope with a wide variety of products and new technology coming to market.

• Overall management of device evaluation has been poor.

In the past, PMDA took many improvement measures to speed up the process in order to cope with global criticism of its so-called“device lag.” But further improvement is definitely required to speed up the process.

According to the medical device subcommittee of the American Chamber of Commerce in Japan (ACCJ), the comparison of evaluation time between 2003 to 2005 and 2005 to 2008 showed interesting results.

The evaluation time (from submission to approval) of devices equivalent to those requiring premarket approval in the United States fell from 26.6 months to 21.1 months. At the same time, 510(k) equivalent medical device evaluation time went from 25.6 months to 12.1 months. Despite this drop, more time was required for device companies to complete the application process. As a result, the reductions in approval time didn’t make much overall difference. In response, PMDA has said it will streamline the process to enable better overall application and review management.

The medical device subcommittee of the ACCJ recently was rebranded as the American Medical Devices and Diagnostics Manufacturers’ Association in Japan. The association, which was established on April 1, represents the Japanese operations of United States-based device and diagnostics companies. According to a release from the group, it was established“as an independent organization to foster speed and efficiency when addressing the common advocacy interests of companies formerly represented by the Medical Devices and Diagnostics Subcommittee of the American Chamber of Commerce in Japan. Advocacy activities include providing timely policy recommendations related to regulatory issues, national health insurance reimbursement payments, and health care system reform in Japan, in order to provide global-standard advanced medical technology to Japanese patients.”

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].