Given Japan’s conservative regulatory environment, it should come at no surprise that advertising and promotion of medical devices and pharmaceuticals in Japan is highly regulated and very restrictive. Without shonin, or “approval” of a product, advertising the name, manufacturing process, indications, effects,... Read More
Though most medicine manufactured by foreign joint ventures, large State-owned enterprises, or foreign manufacturers (including imports) is labeled correctly, much of what is manufactured by small domestic producers is not. Product information and labels on locally manufactured products often omits potentially negative... Read More
Regulations in Japan are rapidly changing and the information in this news brief from 2001 may provide outdated information on Japan’s current medical industry. For updated and in-depth information on Japan’s in-country caretaker and distributor search process, please visit our Japan Distributor Search page. A... Read More
Clinical trials are essential in monitoring the safety and quality of all pharmaceuticals. Japan's Ministry of Health and Welfare (MHW) and the drug organization (KIKO) are working with the Pharmaceutical and Medical Device Evaluation Center in Japan to guarantee that safety standards,... 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
Japan's recent economic recession has not slowed the great demand for technologically innovative products that are flooding the Western medical markets. The country's aging population and the government's efforts at deregulating the distribution process are some of the main factors pushing Japan's... Read More
Recent deregulation reforms within the Japanese pharmaceutical market have been applauded by international pharmaceutical companies and associations alike. Major reform efforts include: withdrawal of the reference pricing system, speeding up the approval process for new drugs, more acceptance of foreign clinical data,... Read More
Recovering economies throughout Asia offer promising markets for foreign medical device firms as well as opportunities for local product development and manufacturing. Before the Asian financial crisis, regional medical device markets grew at double-digit rates. Patients wanted the technologically innovative, cost-effective devices... Read More