About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

1997 FDLI Update 1 (1997)

handle is hein.journals/fdliup1997 and id is 1 raw text is: -A ISSUE 1 * 1997 UPDATE Friedman Nam Deputy Commi FDLI Open Hot Celebrates New Future Food Sa Challenges....... Food Nutrition Teaches the Tea Former FDA Commissioners Inside Registering Medical Products in Japan Direct Registration Via the In-Country Caretaker is Often Best ed Lead - Ames Gross ssioner .... 2 Japan is the world's single larg- Despite the excellent prospects J est medical market outside the for exporting medical devices to se United States. Product registra- Japan, there is an obstacle that all Offices... 2 tion in Japan, however, is often foreign medical manufacturers fety complicated and difficult. The face: the legal requirement that all 3 direct registration of medical - medical products be registered products in Japan via the In-Coun- with the Japanese Ministry of Program try Caretaker (ICC) System can Health and Welfare (MHW), chers........ 4 help foreign medical companies Japan's equivalent of FDA. The understand the issues involved in fundamental objective of MHW is registering products directly in to ensure that Japanese citizens S6 Japan via the ICC system. Al- Ames Gross have access to the latest technol- lications Advisory ittee Examines New Opportunities...... Committee Chairs of the 105th Congress.. Every Iss On the Move .................. Making History ............ New Members .............. The Associates' Corner Job Exchange Online .... New Books .................... Calendar of Events ...... though the ICC laws were enacted in 1983, few foreign companies have taken advantage of this 9 strategy due to a lack of knowledge of the laws, the cost of creating an ICC, or a lack of knowl- edge about the distinct advantages of an ICC. .. 10 Despite Japan's economic slowdown in the early to mid-1990s, its market for medical prod- ucts has continued to grow steadily. In 1992, the medical device market grew by 15.8%, in 1993 In by 19.2%, and in 1994 by 12.4%. In 1995, the total size of the market reached $21 billion, larger ue than all other Asian markets combined. During the past few years, foreign imports have ac- .. counted for the vast majority of the increase, while local production has leveled off and ex- 6 ports have declined. During the next few years, as Japan's economy begins to grow again, im- ports of foreign medical devices are expected to 8 grow by five to eight percent annually. The United States enjoys a particularly favor- 8 able position vis-a-vis other foreign participants in the Japanese market. Between 1990 and 1994, 11 U.S. suppliers expanded their share of the total 12 market from 13% to 20.3%. In 1994, U.S. medi- cal devices accounted for 62.3% of Japan's grow- ing medical device import market. ogy in medical devices, and that products are safe and effective. In Japan, medical device manu- facturers and importers are expected to be so- cially responsible. The MHW, therefore, enforces its directive by maintaining stringent quality stan- dards for both medical device products as well as manufacturing or import facilities. Consistent with the MHW regulations, the Japanese govern- ment requires foreign medical manufacturers to maintain a physical presence in Japan in order to ensure a prompt response to safety problems re- lating to a medical device's use. To meet the Japanese government's require- ments of in-country representation, a foreign medical manufacturer has two choices when en- tering the Japanese market: * Establishing an office in Japan and selling its products through its sales force, a Japanese distributor, or a combination of the two; or * Exporting its products to Japan and arrang- ing for a distributor or importer to sell them there. If a foreign medical manufacturer chooses to set up an office in Japan, the manufacturer can establish a representative office, a branch office, a joint venture, or a subsidiary corporation. The Continued on page 10 Digitized from Best Copy Available DLI . .. a non-profit institute dedicated to advancing the public health by providing a neutral forum for critical examination of the laws, regulations, and policies related to drugs, medical devices, other health-care technologies, and foods.

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most