Medical Translation Insight

Device manufacturers love to complain about the Japanese regulatory process. It is often criticized as among the most difficult and slowest in the world. Now it looks like this so-called "device lag" may disappear.

In December 2008, Japan's Ministry of Health, Labor, and Welfare (MHLW) released a five-year plan to streamline the medical device regulatory process. Funded by an increase in user fees, MHLW's goal was to triple the number of medical device reviewers. At the time, The Gray Sheet suggested that this larger number of reviewers would form the basis for a three-part reform:

1. The government will allow all low-risk Class II products to be approved via a third party (similar to notified bodies used in the European Union).
2. Three review tracks would be established - one for brand-new devices (Shin, in Japanese), on for improved devices (Kairyo), and a one for "me-too" products (Kohatsu), with separate reviewers specializing in each track.
3. Japan will reconsider clinical data requirements, allowing a greater portion of products on the market without pre-market human testing (bringing it more in-line with U.S. practices).

What do all of these efforts get medical device manufacturers? The standard process for the approval of new devices is projected to be cut to 19 months (12 months pre application plus 7 months post application). Overall, MHLW aims for a median approval time of 14 months for regular new medical devices and 10 months for specially designated fast-track new medical devices.

Six months into the "action plan", MHLW has done a terrific job at hiring reviewers and keeping industry informed about its progress. And reactions from the device industry are ecstatic.

Clinica reports of "momentous changes" [PDF link]. The Gray Sheet sees a "spirit of transparency". And AdvaMed "applauds" all of the progress being made.

What a difference a year makes...

Further reading:

• U.S. medical device manufacturers in Japan now have an association of their own.
• Even with these improvements, to be effective in Japan device manufacturers deploy customized translation process for Japanese regulatory submissions.
• Japan continues effort to speed up device reviews is a good overview of the Japanese government's efforts to eliminate the "device lag".

ForeignExchange Translations provides specialized medical translations for regulatory submissions, labeling, and safety reports - in Japanese and dozens of other languages. Contact us to find out more.