It found that approval times in Japan were longer than those in other principal global markets. As the leader in developing and exporting innovative medical technologies, the United States may be disproportionately affected by this.Even though reform was enacted in 2005, significant challenges remain, especially for small and mid-sized businesses, the report states. And if the GHTF chair can't succinctly explain how Japan's approval system works, don't expect them to be overcome any time soon.