Effective January 14th, Japan’s Ministry of Health, Labour, and Welfare (MHLW) issued new guidelines for medical device packaging. The Guideline of Package Insert for Medical Devices aims to provide physicians and consumers with clearer, more comprehensive product and usage information to prevent... Read More
The Japanese Ministry of Health, Labor and Welfare (MHLW) recently passed a new foreign reference pricing policy for medical equipment that will take effect on April 1, 2002. The decision has sparked controversy, as many U.S. observers believe the new policy violates... Read More
Mergers and acquisitions in the Japanese healthcare industry are on the rise. The strength of the dollar (versus the yen) and deregulation in Japan have many U.S. and European drug companies planning to increase their presence in Japan, where pharmaceutical sales are... Read More
Compared to the U.S. and many European countries, the biotechnology industry in Asia is embryonic. However, in recent years, several Asian countries have designated the expansion of biotechnology as crucial to their economic development. Some governments in Asia have thus begun taking... Read More
The Asian market as whole is huge, comprising some 3.5 billion people -- 60% of the world total. Each country, though, has its own culture, business norms, and regulations, and companies investing in the region need to be aware of the differences.... Read More
In late September 2001, the Japanese health authority released an early draft of its new medical industry reform plan. Though it seems unlikely that the plan will be ready by the April 2002 target date, the draft document gives insight into changes... Read More
This case study examines the issue of registering medical device products in Japan. The two main components, Company X and Importer Y, are used to demonstrate how a U.S. manufacturer can have direct registration of their medical device products, which allows the... Read More
Japan’s pharmaceutical market is the second largest in the world – larger than that of France, Germany, and the UK combined. The total market size is between $50 and $55 billion. However, the market size, measured in dollars (or yen) is shrinking.... Read More
Despite U.S. companies’ relative success in the Japanese medical device and pharmaceuticals markets, over-regulation has continued to hamper U.S. cutting edge products’ access to Japan’s market. This hurts both U.S. manufacturers and Japanese citizens, who are denied access to innovative, cost-effective, life-saving... Read More
As Asian countries continue to deal with growing elderly populations and the proliferation of heart disease and cancer as leading causes of death, healthcare systems are being revised and new medical device imports are in high demand. Despite Japan's strict regulatory regime... Read More