In 2002, the Japanese Ministry of Health, Labour and Welfare announced sweeping changes to its Pharmaceutical Affairs Law and the regulations governing the sale of medical devices in Japan. Japan represents a 10% share of the global medical device market, and it is vital that device manufacturers have a thorough understanding of the revised PAL if they wish to gain legal market entry.
This presentation gives an introductory overview of the structure of the Japanese regulations, and highlight the main requirements device companies must meet in exporting their products to Japan.
Japan's Revised PAL: What Device Companies Need to Know was presented by Steve McRoberts, Global Principal Engineer, Medical Regulatory Programs, of UL International (UK) Ltd. on 2006-01-11. For more details, or to purchase a download, please visit our site www.fxconferences.com
