AdvaMed Applauds Japan on Medical Device Process
Posted on December 18, 2008 @ 11:00 am
The Advanced Medical Technology Association announced its support Wednesday on steps taken by the Japanese government to speed up the availability of innovative medical technologies to patients by creating a more efficient medical device review process.
“The five-year action program will triple the number of medical device reviewers in Japan by 2013 and set stringent performance goals to substantially improve review times in exchange for higher industry user fees. Under the action program, Japan also has committed to streamline its review requirements and processes through improvements in key areas such as partial change requirements, stability testing requirements, and clinical data requirements. In addition, device reviewers will receive extensive training so they can meet the new performance goals," said Stephen J. Ubl, president and CEO of AdvaMed.
The association previously criticized Japan for having the slowest approval times among major industrialized countries for medical devices.