Taiwan’s Quality System Documentation (QSD) system requires device manufacturers to pass a “paper audit” before medical devices can be registered in that country. QSD is part of Taiwan’s Good Manufacturing Practices (GMP) system, implemented for medical devices in early 1999. Under Taiwan’s... 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
Despite sluggish economies in some countries, Asia still represents future growth opportunities in healthcare products. Over the next 20 years, Asian healthcare markets are expected to grow at a rate two and a half times that of the West. A rising standard... Read More
China’s $22.5 billion pharmaceutical market is the second largest in Asia, after Japan, and foreign drug imports and pharmaceutical investment in China will likely increase as China enters the WTO. Anticipating an influx of foreign pharmaceuticals, the Chinese government established the State... Read More
Regulations for medical devices vary by country in Asia and are always changing. India and Malaysia, which previously did not have regulations for product registration, have recently adopted stricter and more comprehensive guidelines. In Taiwan, where registration rules were different for domestic... Read More
This article is a review of Japan's transforming medical device market. Topics include Japan's medical community, the economy, deregulation issues, pricing and reimbursement, the eldercare market, market entry strategies, and distribution strategies. Figures and statistics are included as guides for each topic.... Read More
Japan's medical device market is worth about $23.4 billion and is the second largest in the world, after the U.S. This article goes over some of the key factors in Japan's medical device market, including product registration, reimbursement approval and market entry... Read More
Despite the difficulties foreign companies sometimes face when entering the Japanese medical device market, strong demand for more technologically advanced products and sophisticated medical treatment has opened up the market more to manufacturers who can meet this demand. The Japanese government is... Read More
China's pharmaceutical market is booming, and with the formation of the State Drug Administration (SDA) in 1998, enforcement of pharmaceutical regulations has greatly improved. An increase in drug supervision, through stricter punishments for drug research, declaration and registration violations, was implemented by... Read More
The Japanese medical market is on the rebound and is expected to grow to 6% annually over the next several years. With 20% of the population over the age of 65 and a growing number of diseases like cancer and heart disease... Read More