Make sure you are prepared for your Japan medical device registration by fully understanding the QMS auditing process. Audits can either consist of a document review or an on-site inspection. This webcast CD will describe how to prepare for your audit and what the process entails. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.

Japan’s long recession is over. After a frustrating period of starts, stops, and even reverses in economic growth (1990-2002), Japan’s GDP growth has stayed near or above 2% since 2003.

With its affluent and aging population, Japan is the second-largest medical market in the world. Over the past ten years, Japan has seen its elderly population rise sharply, with those over 65 years of age increasing from 10% of its total population to over 20%. With a declining overall population, a low birthrate, and a shrinking ratio of productive population to aging population, maintaining adequate healthcare has been a priority of the Japanese government. From 1997 to 2003, government spending on healthcare increased from 6.8% of GDP to approximately 8.0%. Japan remains a key market for medical devices, especially higher-end products, with its medical device market still towering over the rest of Asia’s at $25 billion.

This report provides a detailed overview of Japan’s most recent medical device regulations post April 1, 2005. All new regulatory material cover s issues from April 2005 through January 2006. This report outlines more details on the regulations beyond what was covered in the January 26, 2006 webcast. Specific topics include the new requirements for master file registration, new requirements for applying for a foreign manufacturer certificate, new requirements for GCP compliance review, new post-marketing safety measures, new labeling requirements, and new adverse event reporting requirements, among others.

This webcast provides an overview of Japan ’s most recent medical device regulations post April 1, 2005.  Topics covered in the webcast include the new requirements for master file registration, new requirements for applying for a foreign manufacturer certificate, new requirements for GCP compliance review, new GVP requirements, among others.

Japanese healthcare standards are among the highest in the world and the Japanese spend close to $300 billion per year on healthcare. Even though this number is far less than the $1.8 trillion spent by the United States every year, Japan’s demand for better and safer healthcare is rising as the country’s elderly population continues to increase. Subsequently, the Ministry of Health, Labor and Welfare (MHLW) has become more aware of the need to improve the country’s regulatory and safety environment for medical devices.

This presentation will provide an overview of the changing regulatory environment for medical devices in Japan .  Information outlined in the presentation includes the changes in Japan ’s medical device registration process following the implementation of the new Pharmaceutical Affairs Law in April 2005, and the new Market Authorization Holder system.