Japan’s Ministry of Health and Labour Welfare (MHLW) announced an update on reimbursement prices for medical devices in 2012. The update includes increased reimbursement for products which have innovative technology. This new incentive for innovative products is intended to encourage manufactures to introduce the latest medical technology in Japan at the same time as in the U.S. or EU.
In order to qualify for this incentive, medical products must have entirely new technology or significantly improve on existing technology in Japan. The incentive requires that manufacturers submit an application to the PMDA either before or within 180 days of submission to the US FDA. Finally, manufacturers must answer all PMDA inquiries within 240 days during the reviewing process (150 days for expedited review).
Reimbursement prices tend to decline every two years as a result of the Japanese government’s budget, competition, and new entrants. However, products that qualify as innovative technology will not be affected by the first reimbursement price update after the product obtains final reimbursement approval.