Japan's Medtech Regulatory Rebirth
Executive Summary
Although Japan has a reputation as a difficult market for new medical products to enter, the government and several public/private initiatives are making ground-breaking efforts to change that image. Several initiatives--some modeled after US Food & Drug Administration practices--will be launched in 2009. These changes, as well as others made in 2008, already are cutting into the drawn-out review times that manufacturers historically have had to face as a normal part of doing business in the country.