Reimbursement Trends for Medical Devices in Japan

In conclusion, with the regulatory review speed by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) becoming competitive with FDA for PMA devices and the time to reimbursement being about a year after regulatory clearance with 80% of U.S. list price, Japan might be the best market, after the United States, to enter as an international market for many new companies. For 510(k) devices, the speed of reimbursement will be the same, although the speed to regulatory clearance remains a challenge. How soon a U.S. manufacturer submits the regulatory submission to PMDA is still the most substantial gap in term of commercialization speed between the two countries. This analysis shows that when it comes to companies’ strategy in Japan, the sooner they act, the better.      
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news