IVD Technology
Magazine
IVDT Article Index
Originally published November, 1997
HIMA urges reform of Japanese IVD regs
The Health Industry Manufacturers Association (Washington, DC) is recommending that Japan's Ministry of Health and Welfare regulate and treat IVD products as medical devices rather than as pharmaceuticals.
The suggestion was made as part of a larger list of initiatives for the Japanese medical technology sector submitted to the Clinton administration as background for deregulation talks between the two governments.
According to HIMA, recent studies suggest that inefficiencies in the Japanese system are to blame for the high cost of many medical products in Japan. "Deregulation measures that expedite access to the Japanese market will further help lower prices and, in this case, health-care costs," says Ed Rozynski, HIMA's executive vice president.
The association says that "industry is prepared to identify some current regulations that need to be changed or relaxed for IVDs."
