Full article reprinted from "The Gray Sheet" - September 21, 2009
Japan is rolling out a new three-track medical device review system based on the novelty of the product, Japanese device reviewers said last week. Read more...
Japan Rolls Out Three-Tiered Review System For Medical Devices
Full article reprinted from "The Gray Sheet" - September 21, 2009
Japan is rolling out a new three-track medical device review system based on the novelty of the product, Japanese device reviewers said last week.
The new review paradigm is part of Japan's five-year "action program," launched in April, aimed at accelerating device reviews in Japan, which has historically had some of the longest review cycles in the world (The Gray Sheet' Dec. 22, 2008).
Once the system is fully implemented, devices will be reviewed by one of three teams within Japan's Pharmaceuticals and Medical Devices Agency (PMDA): brand-new devices (Shin, in Japanese), improved devices (Kairyo) and "me-too" devices (Kohatsu).
"Before the introduction of the three-track system, one review team reviewed brand-new devices, improved devices and me-too devices," Yuka Suzuki, director of PMDA's Office of Medical Devices I, explained at the annual Regulatory Affairs Professionals Society meeting, held Sept. 13-16 in Philadelphia.
As the Japanese agency hires more reviewers - another initiative of the five-year action program - the three-track system is beginning to take shape. By 2013, Japan hopes to have 104 device reviewers on staff. It currently has 47, and another will join by year end.
The reviewers expect review times will be longest for brand-new devices, shorter for improved devices and shortest for me-too devices.
Japan Unveils Substantial Equivalence System
This year, PMDA began implementing a substantial equivalence system within the me-too track, similar to FDA's substantial equivalence system for establishing that a moderate-risk, Class II device is substantially similar to a legally marketed predicate device.
Me-too applications are to be submitted in a special "Kohatsu-style" format, making it easier and faster for reviewers to evaluate substantial equivalence, PMDA device reviewer Madoka Murakami said at the conference.
"This means perfection of submission file is needed in the Kohatsu review."
In the new system, firms will be notified as to whether their submissions are sufficient within two weeks of filing, Murakami said.
Me-too device submissions will be simpler than brand-new device submissions, PMDA's Suzuki noted. The agency plans to create a guidance document on me-too submission requirements.
For the brand-new device track, Japan is hoping to develop a system for reviewing preclinical device data even before the clinical trial is complete, similar to FDA's modular PMA system, Suzuki said. This could allow reviewers to estimate how much clinical data is needed based on the earlier data.
A separate review team has been formed for reviewing submissions of certain specified device modifications, such as a change to a similar material, or a change of sterilization systems. Specified change, or Toku-Hen, applications are reviewed within about two months, the Japanese officials said.
Reviews of brand-new devices currently take about 21 months total; with new reviewers and the new tiered system in place, Japan hopes to reduce this to 14 months by fiscal year 2013.
Improved device applications now take about 16 months total if they include clinical data, and 11 months total if they do not include clinical data. PMDA hopes to cut this down to 10 months by 2013.
Me-too reviews should be shortened from eight to four months by 2013, the officials project.
In the spirit of transparency, PMDA says it will begin posting approved device summaries and other related information on its Web site, also beginning this year.
- Jessica Bylander
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