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
Physicians often run (and sometimes own) local hospitals in Japan. Because of this, they are the key decision-makers for most major hospital purchases. Thus, it is imperative that a manufacturer’s medical device appeals to Japanese doctors during both the pre-approval and marketing... Read More
The importation of medical devices that have not yet been approved by the Japanese government falls into two broad categories, based on the purpose of the importation. The first category is for products being imported for personal use by individuals, while the... Read More
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Regulations in Japan are rapidly changing and the information in this news brief from 2001 may provide outdated information on Japan’s current medical industry.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
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
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
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