WASHINGTON, D.C. - Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement regarding the Japanese government's approval of an Action Program that will substantially improve medical device approval times:

"AdvaMed is pleased the Japanese government has adopted a program that will speed the availability of innovative medical technologies to patients in Japan by creating a more efficient and predictable 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.
"The Action Program is a good start toward bringing Japan's approval procedures and review times closer to those in the United States and Europe, and we look forward to working with Japanese regulators to implement the program effectively for the benefit of Japanese patients."

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

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