Japan mulls shortening medical device regulatory process

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Japan considers easing up on strict regulatory approval process. Source: Kara & Associates  

Japan is considering speeding up its lengthy approval processes, which typically delay the introduction of new products in that country.

Japanese regulatory authorities have already adopted new reimbursement measures as of April 1, Philip Agress, vice president for global strategy and analysis at AdvaMed, told Finance & Commerce (F &C). Additionally, discussions between the United States, Japan and trade groups—concluded in early July—point to the possibility that companies may no longer be subjected to a full-blown approval process required for any product changes.

“Japan’s regulatory approval process is the slowest in the industrialized world,” Agress told F&C. “It’s case by case (depending on products) but a one- or two-year delay is not at all unusual, sometimes more.”

The potential for a smoother, speedier approval process signals a change in the way the Japanese government has traditionally looked at review processes of medical devices F&C reported. For example, when companies have conducted clinical trials elsewhere, Japanese authorities have required that clinical trials be conducted on Japanese patients before products can be sold in that country.

“On paper, the requirements are the same for all companies (whether Japanese or otherwise), but in practice, sometimes foreign companies have increased burdens,” Agress told F&C.

The Japanese market for medical devices is roughly $20 billion, second to only the U.S. market, F&C reported. Changes in the way products are approved now may allow U.S. companies greater access to the Japanese market.

While the reimbursement changes have passed, F&C said it remains to be seen whether Japan will actually adopt changes to its regulatory approval structure for medical device companies. Agress said he is hoping to see a draft of proposed changes in August.