JAPAN MEDICAL DEVICES REGULATIONS - JGMP
Japanese Pharmaceutical Affairs Law (PAL)
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).
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.
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.
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.
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.
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.
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."
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.