The Advanced Medical Technology Assn. recently returned from a trip to Japan where they pushed for a faster medical device approval process.
AdvaMed, which represents the device industry, said its member companies are "increasingly passing Japan by" because of the country’s onerous regulatory system and "uncertain" reimbursement rules that are based on comparisons with prices in unrelated foreign markets.
"Despite some recent improvements, Japan’s medical device approval process is still considered the most burdensome in the world," said AdvaMed CEO Stephen Ubl in prepared remarks.
The trade council reported that American device and diagnostic firms employ more than 13,000 people in Japan, and the country is AdvaMed member companies’ largest market outside the U.S. The relatively high cost of doing business there, in addition to the harsh regulatory enviroment, has AdvaMed "very concerned" about Japanese policies.
Ubl went to Tokyo with AdvaMed chairman and Abbott Medical Optics president James Mazzo and completed a "successful series of meetingsa" with 21 members of the Japanese Diet, the country’s bicameral legislature, and officials from its regulatory agencies, according to AdvaMed.
“Our meetings this week were very productive, and we look forward to working with officials in Japan to ensure that regulatory and reimbursement policies are in place that facilitate Japanese patient access to the most safe and effective medical devices and diagnostics available,” said Mazzo in prepared remarks.