Japan continues effort to speed up device reviews.

The Japanese regulatory process for medical technology often is criticized as among the most difficult and slowest in comparison with other Western systems such as those in the United States and Europe. This so called "device lag" has drawn the ire of international medical device manufacturers as well as clinical professionals in Japan.

Despite major reform of the regulatory system--the Pharmaceutical Affairs Law enacted in 2005--many people still feel that the situation has not improved and perhaps has even gotten worse. To improve the situation, Japanese authorities have introduced new administrative measures, such as preliminary consultation services and a faster approval program for prioritized high-need medical devices, among others. Participation in international efforts such as the Global Harmonization Task Force, bilateral trade talks with the United States, Harmonization by Doing (a pilot program between the U.S. Food and Drug Administration and Japan's Pharmaceuticals & Medical Devices Agency [PMDA]) and participation in critical industry seminars and events have helped to speed up the regulatory process.

These efforts, though important, have been focused on highly advanced medical technologies such as drug-eluting stents and artificial hearts. Fundamental improvements on conventional and more mainstream medical device technologies largely have been ignored. In December 2008, the Ministry of Health, Labor & Welfare (MHLW) and the PMDA announced an action program for the faster evaluation of medical devices. The objective of this program is to provide more effective and safer medical devices and to make these new medical technologies available quickly to patients and healthcare providers. In order to ensure quality, effectiveness and safety, the new system will include collaboration with academia and private sectors. To bring about change, the new program will implement key steps.

Increase Reviewers and Improve Quality

By fiscal 2013, the PMDA gradually will increase its number of reviewers from a current base of 35 to 104, and will establish a training and education program for reviewers in cooperation with academia and base it on the FDA's evaluation program in the United States.

A standard operating procedure will be implemented that will be in place starting in April.

Introduce a Three-Track Evaluation System

Depending on the level of novelty, medical devices shall be classified into three levels: new medical devices, improved medical devices and "me-too" medical devices (devices with a predicate technology already on the market), with each evaluated by a specialized team.

The new evaluation system will simplify the application forms (including partial changes) and may shorten the evaluation process for minor modifications, such as changing a raw material in a device that does not affect the function or efficacy of the device.

Once part of a previous review process in Japan, the three-track evaluation system was discontinued when new regulatory rules were implemented in 2005. Taking into account current criticism, MHLW/ PMDA decided to revive the previous review method, which will be rolled out in a step-by-step fashion beginning in April.

Introduce a Pre-Evaluation System for New Devices

Even prior to completion of clinical trials, technical assessment of a new medical device, as well as pre-clinical data, such as biological, electrical and functional data, can be evaluated in advance.

Clinical data will be reviewed as soon as it is available. This new method will allow the faster approval even if a device requires clinical trials to prove its clinical efficacy and safety. This system will be introduced in fiscal 2010. Face-to-face consultations such as pre-clinical consultation and pre-application consultation will become more frequent, according to the MHLW/PDMA.

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These services are very effective for device manufacturers to ensure that they're exploring the correct regulatory pathway and avoid wasting time, money and effort. The caveat is that the PDMA has a limited number of reviewers and companies may have to endure a waiting list. Additional hires should help speed up this process.

Provide Standardization of the Evaluation Process

By establishing evaluation standards and guidelines, MHLW/PMDA will accelerate the process by introducing a clear definition of the scope of the application for a partial change or minor change, outlining necessary cases for clinical trials, and covering a range of products with one application.

Standardize the Evaluation Period, Process Management

The standard process for the approval of new medical devices is projected to shorten to a maximum of 19 months (pre-application 12 months/after application seven months). Companies' efforts in speeding up the process will be a critical part of the puzzle, as the government's response is only as good as the information submitted by medical device manufacturers. The goal is a standard median approval tithe of 14 months for regular new medical devices and 10 months for specially designated fast-track new medical devices.

Evaluation times also will speed up for improved medical devices and me-too medical devices. The median evaluation time target is 10 months for improved medical devices with clinical trials and six months when clinical trial data is not required. Me-too medical devices will be reviewed in four months time after submission of the application. These timelines are projected to be accomplished by fiscal 2013.

Evaluation documents of approved new medical devices shall be open to the public through PMDA's official Web site, www.pmda.go.jp. Also as part of the plan, the government will allow all low-risk Class II products to be evaluated by a third party, much like notified bodies used in the European Union. At present, only a portion of Class II products can go through the third-party process. This move is expected by fiscal 2011.

A meeting between public and private sectors will be held twice a year to monitor and review the progress of these new evaluation goals and processes.

These action programs are widely supported by the industry; however, to accomplish these challenges, the PMDA needs increased financial support from the industry.

The PMDA and industry representatives are negotiating the increase of user fees for PMDA's regulatory services. The proposed increase will be nearly double current fees. The largest fee increase would impact new medical devices in Class IV, the highest-risk category in Japan, while lower-risk devices would see more moderate fee hikes. Exact numbers should be available soon.

Clearly, the tradeoff is that if approvals become significantly faster, it would be an overall win for the industry and, ultimately, the patient.

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 [e-mail].