Japan’s Ministry of Health, Labor, and Welfare (MHLW) released a plan in December 2008 to speed the medical device regulatory process over the next five years. Japan’s stringent medical device regulations and caution in approving foreign devices has historically caused a substantial device lag. In other words, medical devices take significantly longer to receive approval in Japan than in most other countries. Due to the number of industry complaints, in recent years, the Japanese government has taken steps to streamline its regulatory process, culminating in the new five-year plan.
Japan plans to clarify the review process by categorizing medical devices into three groups based on their level of novelty: new medical devices, improved medical devices, and “me-too” predicate medical devices, which are similar to U.S. 510(k)-approved devices. Predicate medical devices are those that are demonstrated to be substantially equivalent to a product that already has marketing approval in Japan. Beginning in 2011, Japan plans to set up a 3-track review system such that each of the three groups will have its own specialist team for review and approval.
Japan also plans to introduce an initial evaluation system for new medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) will be able to do a pre-application review of data such as biological safety testing, electrical safety testing, and performance testing without waiting for clinical trial completion. This system should be implemented in stages starting in 2010.
According to the new plan, the PMDA’s goal for application review time will be around 7 months for new devices and 4 months for already-developed devices. For improved devices, if clinical data needs to be submitted, then the goal for review time will be 10 months. If no clinical data needs to be submitted, the goal for review time will be 6 months.
To help achieve these shorter review times, all Class II (low-risk) devices will be reviewed for approval by third parties (similar to Notified Bodies) by 2011 so that the PMDA can focus more resources on reviewing the higher-risk Class III and IV medical devices. Additionally, the PMDA will increase its medical device reviewers from 35 to 104 by 2013.
The PMDA’s plans also include improving the quality and quantity of PMDA consultations, including those for clinical trials, and clarification of review standards and procedures, which are often ambiguous in Japan.