Updated: 12/08/00.

Summary:

On March 17, 2000, Japan's Ministry of Health and Welfare (MHW) issued a seirei, or cabinet order, to amend the Pharmaceutical Affairs Law to revise procedures for processing product approval applications for medical devices. This order became effective on April 1, 2000. Under the new system, the previous application category for medical device approvals was restructured into three categories; 1) "new devices" 2)"improved or modified devices," and 3) "me-too devices." Under the new policy only "me-too devices" are now subject to equivalency review by the Japan Association for the Advancement of Medical Equipment (JAAME).

The purpose of this measure is to remedy the problem of redundant application reviews of product approval applications by two separate agencies, the Japan Association for the Advancement of Medical Equipment (JAAME) and the Pharmaceutical and Medical Device Examination Center (PMDEC). The elimination of redundancies in the review process is intended to expedite the medical device approval process.

Background:

In July 1995, in an effort to accelerate the process for reviewing medical device product approval applications, MHW granted the Japan Association for the Advancement of Medical Equipment (JAAME) the authority to perform a portion of the review procedure. The JAAME's expanded role applied to making the determination of equivalency between a "me-too" medical device and other classes of devices. A device determined to be equivalent to already approved products, benefited from less stringent review. New devices, those identified as having a "new structure," were excluded from this expansion of JAAME responsibility.

In July 1997, in order to further expedite the review process, MHW established the Pharmaceutical and Medical Device Examination Center (PMDEC) to perform evaluations, other than the equivalence investigation. PMDEC evaluations were to be conducted, whenever necessary, after the investigation by JAAME. However, in practice, the PMDEC has often re-evaluated the applications recommended as me-too devices by JAAME, resulting in delayed product approvals. MHW designated the JAAME with the authority to evaluate and make recommendations on the approval of "me too" devices; therefore, PMDEC added no value by re-evaluating such applications.

Given the rapid innovation that has become the norm in the medical device industry, and the corresponding shortening of product life-cycles, even modest delays in bringing new products to market can result in large potential revenue losses for manufacturers. As a result, device manufacturers marketing their products in Japan have watched with increasing concern as redundant application reviews have delayed product approvals.

In trade discussions conducted under the auspices of the Market- Oriented, Sector-Selective (MOSS) Medical Device and Pharmaceutical Agreement, the U.S. Government (USG) has asked Japanese Government authorities to take measures to prevent redundant regulatory review by PMDEC and JAAME in the approval of me-too medical devices. The USG has specifically sought to ensure that decisions made by review personnel are treated as binding commitments by the reviewing institution and are binding on other reviewers later in the review process.

In the Second Joint Status Report (JSR) of the U.S.-Japan Enhanced Initiative on Deregulation and Competition Policy, released in May 1999, MHW agreed to ensure that the consistency and speed of the approval process for medical devices will be improved, and to take necessary measures to meet this goal by April 1, 2000. At bilateral trade discussions held in February 2000, MHW officials reported that device applications will be organized into three categories in April 2000. The categories will be designated as "new devices", "improved or modified devices" and "me-too devices." Under the new system for classification of applications, MHW will no longer requires equivalency review for "new devices" and "improved or modified devices" at JAAME. These applications will be exempt from JAAME scrutiny and be reviewed only at PMDEC. JAAME will only conduct equivalency review of "me-too devices."

MHW has issued a notification describing items necessary to determine the "equivalence" of a given medical device. It is the applicant's responsibility to make a judgement under which classification category their products should be submitted for review.

U.S. Department of Commerce, Commercial Service Japan's Comment:

In 1999, MHW received approximately 3,000 medical device approval applications. Roughly 90 percent of these devices were judged to be "me-too" products. The remaining 10 percent, or 300 applications, were determined not to be partially equivalent by JAAME. Within these 300 applications, approximately 30 were reviewed as new medical devices with a "new structure."

Under the newly revised system, JAAME would not review those applications identified as "new devices" or "improved or modified devices," which account for about 10 percent of the total applications. Applications for these products would be submitted directly by the applicant to the PMDEC, without need for JAAME involvement.

These changes should, in theory, speed up MHW's medical device approval process. However, if an applied application as "me-too" device is judged as "improved or modified device" at JAAME, that application will be sent back to the applicant with the requirement that it be submitted as an "improved or modified device," resulting in the review process beginning anew at the PMDEC. MHW issued a notification in December 1999 (Notification 1677) to aid companies making the determination as the equivalency of their products. The Ministry has agreed to implement this notification in a manner that ensures data requests do not include asking for proprietary information on other firms' products. Companies have cautioned that, if the notification is implemented too strictly, the level of information required to make an equivalency determination could necessitate device manufacturers approaching their competitors to obtain certain information. Also in response to company concerns, JAAME and PMDEC will answer questions from applicants prior to application submission regarding proper device classifications on request. Therefore, it is recommended that applicants use this consultation process to the maximum extent to avoid any misdirected or delayed applications.

For more information on opportunities in the Japanese market, please contact:

Commercial Section of the U.S. Embassy, Tokyo (CS Tokyo)
1-10-5 Akasaka Minato-ku Tokyo 107 Japan
Hiroyuki Hanawa, Commercial Specialist
Phone: 81/3/3224-5083
Fax: 81/3/3589-4235