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Japan

JAPAN MEDICAL DEVICE MARKET





TITLE:                   MEDICAL DEVICE MARKET

SUBJECT COUNTRY(IES):    JAPAN

POST OF ORIGIN:          TOKYO

SERIES:                  INDUSTRY SECTOR ANALYSIS (ISA)

ITA INDUSTRY CODE:       MED

DATE OF REPORT (YYMMDD): 990601

DELETION DATE (YYMMDD):  020601

AUTHOR:                  HIROYUKI HANAWA

APPROVING OFFICER:       CRAIG B. ALLEN

OFFICER'S TITLE:         COMMERCIAL COUNSELOR

NUMBER OF PAGES:         18

INTERNATIONAL COPYRIGHT, U.S. & FOREIGN COMMERCIAL SERVICE AND
U.S. DEPARTMENT OF STATE, 1999.  ALL RIGHTS RESERVED OUTSIDE OF
THE UNITED STATES


SUMMARY

The Japanese market for medical equipment and supplies in one of
few sectors where the United States enjoys a trade surplus with
Japan.  U.S. trade surplus has been increasing since 1991. In
terms of yen value, the trade surplus for this sector with Japan
reached 409 billion yen in 1997 from 362 billion yen in 1996.
This market is also one of few industries in Japan which showed
steady growth despite the sluggish Japanese economy in recent
years.  The domestic market for this sector reached approximately
1,937 billion yen in 1997, compared to 1,456 billion yen in 1996
and 1,336 billion yen in 1995.  Imports amounted to 750 billion
yen in 1997, compared to 709 billion yen in 1996 and 588 billion
yen in 1995.  Although the imports showed only 5.8% annual
increase in 1997 as compare to 20.5% in 1996 and 17.5% in 1995,
U.S. products continued to attract Japanese buyers and
physicians.  Of total imports, U.S. products valued at 502
billion yen accounted for 67% of total imports and 26% of the
total market in 1997, compared to 64% and 22.8% respectively in
1996.  Major imported products include catheters, related supply
for diagnostic X-ray, pacemakers, artificial joints, diagnostic
X-ray equipment, MRI systems, laser surgical equipment cardiac
valve prosthesis, etc.

An annual growth rate of only 2% is estimated for the domestic
market.  However, imports from the United States are expected to
see a steady annual growth rate of the 5 to 10% level since U.S
companies are major exporters of innovative medical devices.  In
addition, expected deregulation measures agreed between U.S. and
Japan should further increase the access for innovative U.S.
medical devices to Japanese market.

This report covers medical devices that fall in the Harmonized
System (HS) code of 90.  It does not cover in-vitro diagnostic
(IVD) products as they are classified as pharmaceuticals in Japan
and medical related services.



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A. MARKET HIGHLIGHT & BEST PROSPECTS 1. Market Profile The Japanese medical device market has significantly increased over the last twenty years reflecting greater health awareness and higher expectations with regard to medical care. The medical device market now is as approximately 6 times bigger than it was twenty years ago. This trend will continue as Japan faces a truly aged society with few children in the next century. It is expected that over 25% of the total population will become 65 or older by 2010. In terms of yen value, the market growth was 8.0% in 1995, 12.7% in 1996 and 3.8% in 1997. The market is expected to increase at an annual rate of 2% in the next 2 years. The import market is expected to show greater annual growth. Especially, imports from U.S. are estimated to increase at an annual growth rate of 5-10 % in the next 2 years as U.S. companies continue to be major suppliers of innovative medical devices. Japanese exports have been leaning toward diagnostic imaging equipment that accounted for approximately 38% of total Japanese exports in 1997. By contrast, Japanese imports have been more diverse, including advanced medical devices such as pacemakers, laser surgical equipment, cardiac valve prosthesis and MRIs. Japanese Market for Medical Devices - Figures in million of yen CY-1995 CY-1996 CY-1997 Production 1,336,551 1,456,136 1,514,015 Import 588,700 709,396 750,760 - from U.S. 376,955 444,900 502,835 Export 268,870 299,308 327,517 - to U.S. 72,169 81,980 93,595 Market 1,656,381 1,866,224 1,937,258 - Figures in million dollars CY-1995 CY-1996 CY-1997 Production 14,219 13,359 12,513 Import 6,263 6,508 6,205 - from U.S. 4,010 4,082 4,156 Export 2,860 2,746 2,707 - to U.S. 768 752 774 Market 17,621 17,121 16,010 U.S. Trade Surplus 3,242 3,330 3,382 U.S. Share of Imports 64.0% 62.7% 67.0% U.S. Share of Market 22.8% 23.8% 26.0% Exchange Rate (1 US$/Yen) 94 109 121 Expected growth rate for following 2 years: - Total market: 2% - U.S. exports: 5-10% Source: Yakuji Kogyo Seisan Dotai Tokie Nenpo (annual statistics on production of pharmaceutical and others), Ministry of Health and Welfare (MHW) Note: - In-vitro diagnostics are not in this statistics as IVD's are classified as pharmaceutical in Japan. - Total market equals import plus production minus exports. 3. Best Sales Prospects HS Code Product 9001.30 Contact lenses 9018.11 Patient monitoring systems 9018.13 MRI systems 9018.39 Disposable tube & catheters for blood vessel 9018.90 Laser surgical equipment 9019.20 Oxygen therapy 9021.11 Artificial joints 9021.19 Orthopedic appliances other than artificial joints 9021.50 Artificial cardiac pacemakers 9021.90 Cardiac valve prosthesis 9022.11 Related supply for diagnostic X-ray
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B. COMPETITIVE SITUATION 1. Domestic Production The domestic production of medical equipment has been increasing steadily since 1994 in yen value. Domestic production reached 1,514 billion yen in 1997; up from 1,456 billion yen in 1996, 1,336 billion yen in 1995, and 1,317 billion yen in 1994 or an annual growth rate of 4.0% in 1997, 8.9% in 1996, and 1.4% in 1995. The three major product categories of the domestic production are as follows: diagnostic devices such as X-ray equipment and MRI; artificial internal organ apparatus and assist devices; and surgical instruments. The notable feature of the domestic production is that the diagnostic devices accounted for approximately 20% of the total production over the past decade. This feature also applies for the Japanese export of medical equipment. The export of diagnostic devices amounted to 124 billion yen or 37.9% of the total export in 1997. Three major manufactures of diagnostic devices are Toshiba Medical, Shimadzu, and Hitachi Medical, and those three companies together hold over 70% of the domestic market. Other products that are dominated by Japanese manufacturers are dialyzer (Asahi Medical, Nipuro, etc.), endoscope (Olympus Optical, Fuji Photo Optical, etc.) and hemodialysis apparatus (Terumo, JMS, etc.). 2. Third Country Imports Major exporters of medical devices to Japan other than the United States are Germany and Ireland. Their shares of the total imports are 6.3% and 3.4% respectively in 1997. Other leading third country exporters are Finland, United Kingdom, Switzerland, Belgium and Netherlands. However, their shares of the total imports are even smaller at less than 3.0% in 1997. Although the United States enjoys a significant share of the total imports among the majority of medical device categories, other counties have a good share in dental materials and apparatus, diagnostic apparatus, and diagnostic imaging apparatus. Germany is a leading exporter of diagnostic apparatus (44.1%), the second leading exporter of dental materials and apparatus (25.7%), and the third leading exporter of diagnostic imaging apparatus (18.4%). Netherlands is the second leading exporter of diagnostic imaging equipment (34.3%). 3. U.S. Market Position The largest exporter of medical device to Japan has been the United States, and the U.S. share of both the import market and total market has been increasing. Imports from the U.S. accounted for 67.0% of the import and 26.0% of the total market in 1997, compared to 62.7% and 23.8% respectively in 1996, even though the Japanese yen depreciated against the U.S. dollar to yen 121 in 1997 from yen 91 in 1996. This trend is expected to continue in coming years as the U.S. continues to introduce high quality and innovative medical devices such as pacemakers, artificial joints, MRI systems, laser surgical equipment, etc. to Japanese market. U.S. companies offering advanced medical equipment such as MRI systems, CTs, advanced diagnostic equipment, angiograph equipment and other innovative products with high initial price should benefit from the Overall Greatest Value Methodology (OGVM), one of the deregulation measures set by the Japanese government in 1999. Japanese local governments are now authorized to utilize the OGVM and procure products based on the best overall value for their performance and specification requirements, not simply on the initial cost of the products. This is a significant development for U.S. companies offering innovative and superior performance products. Following is a list of major U.S. manufacturers in Japan in terms of sales in 1998; Baxter, Boston Scientific, Medtronic, Baush & Lomb, Alcon, and Becton Dickinson. Other U.S. manufacturers that are active in Japanese market include Guidant, Hewlett Packard, Johnson and Johnson, Medtronic, General Electric, etc.
C. END USER ANALYSIS The end user is one of the following professionals; physicians, dentists, nurses, physical and occupational therapists, dental hygienists, radiology technicians and clinical laboratory technicians. Although hospital administrators are becoming cost conscious, medical professionals such as physicians and technicians are still key decision-makers when selecting devices for their hospitals and clinics. In general, those medical professionals regard U.S. medical products as advanced and innovative products. The numbers of medical care institutions in 1997 were 9,413 hospitals (with 20 beds or more), 89,292 general clinics and 60,579 dental clinics. The numbers of hospital has been decreasing since 1990. On the other hand, the number of general clinics, especially without beds, and dental clinic has been increasing. In 1990, there were 10,096 hospitals, 80,852 general clinics and 52,216 dental clinics. As regard to medical professionals, there were 240,908 physicians and 85,518 dentists in 1997 that represented 4.5% and 5.5% increase from previous year respectively.
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D. MARKET ACCESS 1. Import Climate Approval and Licensing The Japanese medical market is not an easy one to initially enter. Although there is no tariffs levied on medical devices, this area is highly regulated by the Pharmaceutical Affairs Law of the Ministry of Health and Welfare (MHW). In order to market a medical product in Japan, an importer or a manufacturer must obtain "shonin" approval for safety and efficacy of a medical product. In order handle a shonin-approved product, an importer, a manufacture or a seller needs to obtain "kyoka" license based on its facility, personnel and qualification of a technical director. A foreign manufacture may ask its agent in Japan to obtain the shonin approval. Alternatively, the U.S. company may obtain shonin by using an in-country care taker (ICC) system, even though the U.S. company may have no legal presence in Japan. The ICC system is a direct application whereby a Japanese company acts as a foreign company's in-country representative and processes shonin applications in Japanese and makes itself available for inquiries from relevant parties including the MHW. On the other hand, kyoka license must be in the name of a company (an importer, a distributor or a subsidiary of a foreign company) actually doing business in Japan. The ICC system was introduced in 1983 to alleviate the difficulties in approval transfers of a foreign manufacturer. A foreign manufacture will have a complete control over its products by holding a shonin approval under its name. However, the ICC system costs more than working with an agent. If a foreign manufacture decides to work with an agent, it is recommended that a clause about transferring product approval (shonin) is included in the contract. Time Clock The standard time clock for the approval process is 12 months for new medical devices (devices with new technology or existing technology in new indications or uses), and 4 months for me-too medical devices that are essentially the same devices that are already on the market, and 2 months for approved medical devices with a partial change. It is important to note that the time clock does not include time spent by the applicant to answer questions or supply additional information during the approval process. Time clock starts when an application is submitted to the prefectural authority. An applicant should keep a time clock log to monitor its approval process. The time clock log should indicate not only dates of questions asked and answered but also kinds of questions and names of examiners. Approval Process Applications for import approval of the products are submitted to the prefectural authority that then submits the applications to the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) or Shinsa Center of MHW. Since MHW designated the Japan Association for the Advanced Medical Equipment (JAAME) or Iryokiki Center as the investigation organization regarding the equivalence of structure, usage, indications, performance, etc., process for approval differ depending whether the equivalence investigation to be performed by JAAME. In case of me-too devices, PMDEC submits the applications to JAAME for equivalency investigation. After the investigation by JAAME, PMDEC performs evaluations other than the equivalence investigation whenever necessary. Then, the Pharmaceutical and Medical Device Safety Bureau (PMDESB) makes the final approval based on the results of the investigation. PMDESB notifies the result to the prefectural offices for them to issue the approval to the applicant. In case of new medical devices, the devices are discussed by the Central Pharmaceutical Affairs Council (CPAC). PMDEC initially reviews the applications. PMDEC then reports to the evaluation result to PMDESB that then the applications are discussed by CPAC for its recommendations of the approval. PMDESB makes a final decision of the approval after it receives a recommendation from CPAC. PMDESB notifies the result to the prefectural offices for them to issue the approval to the applicant. Medical Device Reimbursement Japan has the National Health Insurance (NHI) system that covers all of Japanese citizens for their medical services provided by physicians including the use of medical devices. Therefore, in order for medical institutions to use approved medical devices, those devices need to be covered by national medical insurance with only a few exceptions. An importer or manufacturer should indicate their intention to apply for insurance coverage and desired class in the Remarks column of the application form upon application of product approval. A product can be categorized in one of the following three classes: Class A: Medical device that technical skill is evaluated in the Tariff (excluding Class B). Class B: Medical device corresponding to specially insured medical materials. Class C: Medical device other than A and B. This class is for a device with new technology. In case of Class A and B applications, if the applicants do not hear from the Ministry within 20 days after the date of approval, the applicants can expect that the insurance procedure are taken as requested. In case of Class C application, if the applicants do not hear from the Ministry within 20 days after the date of approval, the applicants can then submit an application form of medical device insurance with requested information to the Health Insurance Bureau (HIB) of MHW through the Economic Affairs Division (EAD) of the Health Policy Bureau. It can take many months or even years to receive a reimbursement rate for Class C products, since the applicants are often requested to submit domestic clinical data to prove medical usefulness and cost effectiveness.
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Medical Device Deregulation Issue U.S. Government has been discussing deregulation issues including the medical device approval through the Market-Oriented Sector Selective (MOSS) talks with the Japanese government since 1985. MOSS now serves as the venue for the working level discussions under the Enhanced Initiative on Deregulation and Competition Policy. In May of 1999, the Second Joint Status Report on the Enhanced Initiative, which includes deregulation measures for medical devices and pharmaceutical, was announced. Followings are some deregulation measures about medical devices in the Second Joint Status Report: - The consistency and speed of the approval process for medical devices will be improved. Effective review by the Pharmaceutical and Medical Devices Evaluation Center and the Japan Association for the Advancement for Medical Equipment in the approval process will be promoted, for example, by clarifying the criteria of partial change, and criteria to distinguish "me-too medical devices" from "new devices" which require clinical test data, and allowing for continual direct communication between reviewing bodies and the applicant. Necessary measures have begun and continuous progress will take place with the first goal of completing such measures for pacemakers and orthopedic implants (bones and joints) by April 1, 2000. The progress of other items will continue to be discussed in the MOSS. - Accept foreign clinical test data for the approval of new medical devices and pharmaceuticals that meet, or are equivalent to, Japanese Good Clinical Practice (GCP) standards or ICH GCP. - On April 1, 2000, revoke the requirement that clinical data submitted with an application for medical device or pharmaceutical approval must be presented at a domestic conference of specialists or published in an academic journal, and in the interim treat publication or presentation of such data as optional. - From April 1, 1999, a soft contact lenses grouping system has been introduced regarding the testing comparability between chemical disinfectant solutions and soft contact lenses, which will enable a manufacturer to obtain MHW approvals for use of all brands of contact lenses in a group by testing one representative in the group. The complete text of the Joint Status Report is available on the United States Trade Representative's website at http://www.ustr.gov/.
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2. Distribution/Business Practice Distribution Channel Distribution channels for medical devices in Japan largely depend on types of devices and end users, quantity of devices, etc. Some products are distributed by one or two dealers before those products reach the end users, and some are sold directly to the end user by the manufacture or importer. Expensive, high-tech devices such as CTs and MRIs are usually sold directly by the manufacture or importer since expert knowledge is required for installation and support. Government Procurement Also, medical devices can be distributed through government procurement. In order to participate in the procurement, the seller must be qualified based on their history of operations, financial status, etc. Some ministries and agencies have made their procurement information available on their website in both English and Japanese. For example, the Ministry of International Trade and Industry (MITI) has been providing information regarding the procurement of medical and welfare equipment by municipal government through MITI's website (http://www.miti.go.jp/). The Ministry and Posts and Telecommunication (MPT) also has disseminating their procurement information including medical products through their website called "Procurement Pick Up" (http://www.mpt.go.jp/). Also, the Japan External Trade Organization (JETRO) provides the Japanese Government Procurement Database System on their website (http://www.jetro.go.jp/). 3. Financing Public financial institutions, including the Export-Import Bank of Japan and Japan Development Bank, offer low-interest loans to encourage imports. For details on such loans, contact the following organizations in the U.S.: The Export-Import Bank of Japan Representative Office 2000 Pennsylvania Ave., N.W., Suite 3350 Washington, D. C. 20006 Phone: 202-331-8547 The Japan Development Bank New York Representative Office 575 Fifth Avenue, 28th Floor New York, NY 10017 Phone: 212-949-7550
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4. Key Contacts Japanese Government Agencies Evaluation and Licensing Div. Pharmaceutical and Medical Safety Bureau Ministry of Health and Welfare 1-2-1, Kasumigaseki Chiyoda-ku, Tokyo 100-8045 TEL: 03-3595-2431 FAX: 03-3597-9535 Medical Economics Div. Health Insurance Bureau, Ministry of Health and Welfare l-2-1, Kasumigaseki Chiyoda-ku, Tokyo 100-8045 TEL: 03-3595-2577 FAX: 03-3504-1210 Economic Affairs Div. Health Policy Bureau, Ministry of Health and Welfare l-2-1, Kasumigaseki Chiyoda-ku, Tokyo 100-8045 TEL: 03-3591-9579 FAX: 03-3592-0710 Third Party Review Organization Japan Association for the Advancement of Medical Equipment (JAAME) NKD Bldg. 7F, 3-42-6, Hongo, Bunkyo-ku, Tokyo 113-0033 TEL: 03-3813-8571 FAX: 03-3813-8733 Japanese Trade Organizations Japan Federation of Medical Devices Association (JFMDA) Hongo Ishiwata Bldg. 2F 3-38-1, Hongo, Bunkyo-ku, Tokyo 113-0033 TEL: 03-3818-2310 FAX: 03-3818-2448 Japan Federation of Medical Trading & Manufacturing Associations (JFMTMA) 3-39-5, Hongo, Bunkyo-ku, Tokyo 113-0033 TEL: 03-3814-4301 FAX: 03-3814-4302 Japan Association of Medical Equipment Industries (JAMEI) 3-39-1 5, Hongo, Bunkyo-ku, Tokyo 113-0033 TEL: 03-3816-5575 FAX: 03-3816-5576 Japan Association of Medical Device and Material Industries (JAMMI) 2-2-4, Ginza, Chuo-ku, Tokyo 104-006l TEL: 03-3567-6246 FAX: 03-3567-6247 Japan Industries Associations of Radiological Systems (JIRA) 2-1 8-12, Yushima, Bunkyo-ku, Tokyo 113-0034 TEL: 03-3816-3450 FAX: 03-3818-8920 Japan Industrial Society for Artificial Organs (JISAO) 3-37-8, Hongo, Bunkyo-ku, Tokyo 113-0033 TEL: 03-3815-2602 FAX: 03-3815-2507 Japan Dental Trade Association 3-7-5, Ueno, Taito-ku, Tokyo 110-0005 TEL: 03-3836-5286 FAX: 03-3836-5550 Japan Analytical Instruments Manufactures' Association (JAIMA) 3-22, Kanda, Ogawa-machi, Chiyoda-ku, Tokyo 101-0052 TEL: 03-3292-0642 FAX: 03-3292-7157 Japan Association of Physical Therapy Industries (JAPTI) 2-18-13, Hongo, Bukyo-ku, Tokyo 113-0033 TEL: 03-3811-8200 FAX: 03-3813-7011 Japan Contact Lens Association (JCLA) 2-31-24, Yushima, Bunkyo-ku, Tokyo 113-0034 TEL: 03-5802-5361 FAX: 03-5802-5590 Japan Ophthalmic Instruments Association (JOIA) 1-7-10, Fujimi-cho, Chiyoda-ku, Tokyo 102-0071 TEL: 03-5276-9841 FAX: 03-5276-9842 Japan Home Health Care Association (JHHCA) 3-39-9, Hongo, Bunkyo-ku, Tokyo 113-0033 TEL: 03-3818-6047 FAX: 03-3818-2728 The Japan Home-health Apparatus Industrial Association (HAPI) l-6-11, Ebisu-Minami, Shibuya-ku, Tokyo 150-0022 TEL: 03-3793-3121 FAX: 03-3793-3122
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U.S. Trade Organizations Health Industry Manufacturers Association (HIMA) 1200 G Street, N.W., Suite 400 Washington D.C. 20005-8750 TEL: 202-783-8700 FAX: 202-434-7210 Website: http://www.himanet.com HIMA Japan Office c/o Baxter Limited 4, Rokubancho, Chiyoda-ku, Tokyo 102-8468 TEL: 03-5213-5087 FAX: 03-3237-6772 Sub-committee on Medical Equipment and Supplies The American Chamber of Commerce in Japan (ACCJ) c/o Baxter Limited 4 Rokubancho, Chiyoda-ku, Tokyo 102-0085 TEL: 03-5213-5025 FAX: 03-3237-6772 List of Healthcare Consultants AsiaMed Associates Mr. Bruce Drake, Director 4-20-14 Meguro, Meguro-ku, Tokyo 153 Tel: 03-5768-0788 FAX: 03-5721-8869 E-MAIL: consulting@japanbiomedical.com ADMIS, Inc. Mr. Yoshio Mitsumori, Managing Director, Chief Operating Officer 1-6-4 Osaki, Shinagawa-ku, Tokyo 141-0032 TEL: 03-3491-3637 FAX: 03-3491-3683 E-mail: yoshio_mitsumori@cmi.co.jp Website: http://www.admis.co.jp Apex International Inc. Mr. Hirofumi Shimaji 2-50-10 Nogata, Nakano-ku, Tokyo 165 TEL: 03-3388-4774 FAX: 03-3228-0499 APM, Asia/Pacific Medical, Ltd. Mr. Clyde F. Ito, Managing Director Matsubara Bldg. 101, 1-38-28 Matsubara, Setagaya-ku, Tokyo 156 TEL: 03-3321-9333 FAX: 03-3321-8722 E-mail: clyde@gol.com Colby Group International Inc. Mr. Mark A. Colby, President Kamiya-cho Square Bldg. 8F 1-7-3 Azabudai, Minato-ku, Tokyo 106 TEL: 03-5563-1368 FAX: 03-5563-1398 E-mail: mcolby@colbygroup.com Foxmark International Mr. Philip Foxwell, President Tobe Bldg. 4F, 2-9-17 Shiba Daimon Minato-ku, Tokyo 105-0012 TEL: 03-3578-8400 FAX: 03-3578-9011 KMG Japan Inc. Mr. Kyle E. Murphy, Managing Director 1-18-5 Kitazawa Setagaya-ku, Tokyo 155 TEL: 03-5478-0163 FAX: 03-5478-0236 E-mail: kmgjapan@gol.com List of In-Country Care-Takers ADMIS, Inc. Mr. Yoshio Mitsumori, Managing Director, Chief Operating Officer 1-6-4 Osaki, Shinagawa-ku, Tokyo 141-0032 TEL: 03-3491-3637 FAX: 03-3491-3683 E-mail: yoshio_mitsumori@cmi.co.jp Website: http://www.admis.co.jp Colby Group International Inc. Mr. Mark A. Colby, President Kamiya-cho Square Bldg. 8F, 1-7-3 Azabudai, Minato-ku, Tokyo 106 TEL: 03-5563-1368 FAX: 03-5563-1398 E-mail: mcolby@colbygroup.com MBS Co., Ltd. Mr. Yoshiaki Mitsumata, President 6F Akiba Bldg. 3-6-1 Kyobashi, Chuo-ku, Tokyo 104 TEL: 03-5250-0161 FAX: 03-5250-0162 E-mail: yoshisdg@msn.com Website: http://www.seedgroup.com Medical Industries Corp. Mr. Shigeki Suzuki, President 4-2-1 Yushima, Kyorin Bldg., Bunkyo-ku, Tokyo 113 TEL: 03-3818-8575 FAX: 03-3818-8570 E-mail: mic@micjp.co.jp Website: http://www.micjp.co.jp Medical System Consultant, Inc. Mr. Yasuo Okamoto 1-17-7 Nishi-Gotanda, Shinagawa-ku, Tokyo 141-0031 TEL: 03-3490-3851 FAX: 03-3490-3853 E-mail: mesco@gol.com Ota Medical Corporation Mr. Koichi Yamamoto, Sales Manager 22F, Shinjuku I-Land Tower 6-5-1 Nishi-Shinjuku, Shinjuku-ku Tokyo 163-1349 TEL: 03-3340-3240 FAX: 03-3340-3884 Tokyo Medical Services, Co. Ltd. Akinori Morita, Ph.D., Chief Executive Officer Suite #3, 4-21-11 Nishi-Azabu, Minato-ku, Tokyo 106-0031 TEL: 03-3409-0323 FAX: 03-3409-0229 E-mail: a-morita@tkd.att.ne.jp TUV Product Service Mr. Yuji Wada 2-18-3 Sasazuka, Shibuya-ku, Tokyo 151 TEL: 03-3372-4821 FAX: 03-3372-1621 E-mail: ywada@tuvps.com Website: http://www.tuvps.co.jp
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English Publications, Magazines and Papers Following is a list of English publications, magazines and paper. For other publications, please contact the below publishers directly. Publication: Guide to Medical Device Registration in Japan Publisher: Yakuji Nippo, Ltd. 1, Kanda Izumicho, Chiyoda-ku, Tokyo 101-8648 TEL: 03-3862-2141 FAX: 03-5821-8757 Website: http://www.yakuji.co.jp/ Publication: Health and Welfare Statistics in Japan Publisher: Health and Welfare Statistics Association 5-13-14, Roppongi, Minato-ku, Tokyo 106-0032 TEL: 03-3586-3361 Publication: Japan Medical Industry Directory Publisher: Genyosha Publications, Inc. 2-8-2 Shibuya, Shibuya-ku, Tokyo 150-0002 TEL: 03-3407-7521 FAX: 03-3407-7902 Website: http://www.mmjp.or.jp/genyosha/ Magazine: The Japan Medical Review (monthly) Publisher: Japan Publications Inc. Kyoyu Insatsu Bldg. 8F 332-6 Yamabuki-cho, Shinjuku-ku, Tokyo 162-0801 TEL: 03-5227-3654 FAX: 03-5227-3655 E-mail: jpi@jpn-pub.co.jp Website: http://www.jpn-pub.co.jp Paper: Pharma Japan (weekly) Publisher: Oriox Japan Ltd. 3-4-25 Shimomeguro, Meguro-ku, Tokyo 153-0064 TEL: 03-3792-5600 FAX: 03-3792-7500 Trade Fairs and Exhibitions There are numbers of technical exhibitions held in conjunction with annual meetings of each specialized medical society. Although it is in Japanese, a list of technical meetings is available on Internet at http://center2.umin.ac.jp/. Following is a list of major trade shows that provides good opportunity for U.S. medical device manufacturers to participate. Event: International Modern Hospital Show Sponsor: Nippon Omni-Management Association (NOMA) 3-11-8, Sendagaya, Shibuya-ku, Tokyo 102-0082 TEL: 03-3403-5716 FAX: 03-3403-8615 Website: http://noma-businessshow.or.jp/ Location: Tokyo Big Sight (Tokyo Int'l Exhibition Center) Date: July 7-9, 1999 (annual) Event: HOSPEX Japan (International Hospital Engineering Exhibition) Sponsor: Japan Management Association (JMA) 3-1-22, Shiba-koen, Minato-ku, Tokyo 105-8522 TEL: 03-3434-3453 FAX: 03-3434-8076 Website: http://www.jma.or.jp/ Location: Tokyo Big Sight (Tokyo Int'l Exhibition Center) Date: November 9-12, 1999 (annual) Event: Healthcare Information World Sponsor: IDG World Expo Sagamiya Honsha Bldg., 2F 6 Ichiban-cho, Chiyoda-ku, Tokyo 102-0082 TEL: 03-5276-3751 FAX: 03-5276-3752 Website: http://www.idgexpo.com/ Location: Pacifico Yokohama Date: March 3-4, 2000 (annual) Event: Home Health Care Japan Sponsor: Japan Management Association (JMA) 3-1-22, Shiba-koen, Minato-ku, Tokyo 105-8522 TEL: 03-3434-3453 FAX: 03-3434-8076 Website: http://www.jma.or.jp/ Location: Tokyo Big Sight (Tokyo Int'l Exhibition Center) Fukuoka Exhibition Hall Date: Tokyo: June 14-16, 2000 Fukuoka: June 21-23, 2000 (every two years) Event: JETRO Import Fair: Health Care Sponsor: Japan External Trade Organization (JETRO) 2-2-5, Toranomon, Minato-ku, Tokyo 105-0001 TEL: 03-3582-5242 FAX: 03-3505-0450 Website: http://www.jetro.go.jp/ Location: Tokyo Big Sight (Tokyo Int'l Exhibition Center) Date: March 2001 (every two years)
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U.S. Trade Center The U.S. Trade Center is a first class trade center facility in downtown Tokyo operated by Commercial Service Tokyo. The U.S. Trade Center is available for use by U.S. companies and/or their representatives in Japan for individual company exhibits, seminars, and business meetings. The U.S. Trade Center facilities offer an inexpensive American ambiance U.S. companies may wish to take advantage of. For more information please fax 81-3-3987-2447 or send E-mail to ustc@csjapan.doc.gov, or access http://www.csjapan.doc.gov/ustc/. U.S. Trade Center Tokyo Online The U.S. Trade Center, Tokyo - Online is a Japanese-language, Internet-based tool for promoting American exports in the world's second largest economy. Through industry-specific "online exhibitions," U.S. companies can introduce a new product, refer Japanese inquiries, test the market, search for a representative or distributor, and supplement ongoing marketing efforts in Japan. Each company receives an attractive, individual webpage that includes a description of its products and services in Japanese, up to five captioned photographs, and a link to its own homepage. Viewers can send E-mail directly to the U.S. company or its Japanese agent. For more information please fax 81/3/3987-2447 or send E-mail to ustc@csjapan.doc.gov for application materials. To view a sample company webpage go to http://www.csjapan.doc.gov/online/ or find more information on the Japanese market from other menus at www.csjapan.doc.gov.
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ISA Customer Satisfaction Survey U.S. Department of Commerce * International Trade Administration* The Commercial Service ----------------------------------------------------------------- The U.S. Department of Commerce would appreciate input from U.S. businesses that have used this ISA report in conducting export market research. Please take a few moments to complete the attached survey and fax it to 202/482-0973, mail it to QAS, Rm. 2002, U.S. Department of Commerce, Washington, D.C. 20230, or Email: Internet[Opfer@doc.gov]. ----------------------------------------------------------------- * * * About Our Service * * * 1. Country covered by report: _______________________________ Commerce domestic office that assisted you (if applicable): ________________________________________________________ 2. How did you find out about the ISA service? __Direct mail __Recommended by another firm __Recommended by Commerce staff __Trade press __State/private newsletter __Department of Commerce newsletter __Other (specify): _______________________________ 3. Please indicate the extent to which your objectives were satisfied: 1-Very satisfied 2-Satisfied 3-Neither satisfied nor dissatisfied 4-Dissatisfied 5-Very dissatisfied 6-Not applicable __Overall objectives __Accuracy of information __Completeness of information __Clarity of information __Relevance of information __Delivery when promised __Follow-up by Commerce representative 4. In your opinion, did using the ISA service facilitate any of the following? __Decided to enter or increase presence in market __Developed an export marketing plan __Added to knowledge of country/industry __Corroborated market data from other sources __Decided to bypass or reduce presence in market __Other (specify): _______________________________ 5. How likely would you be to use the ISA service again? __Definitely would __Probably would __Unsure __Probably would not __Definitely would not 6. Comments: ________________________________________________________ * * * About Your Firm * * * 1. Number of employees: __1-99 __100-249 __250-499 __500-999 __1,000+ 2. Location (abbreviation of your state only):______ 3. Business activity (check one): __Manufacturing __Service __Agent, broker, manufacturer's representative __Export management or trading company __Other (specify):_______________________________ 4. Export shipments over the past 12 months: __0-1 __2-12 __13-50 __51-99 __100+ May we call you about your experience with the ISA service? Company name: _______________________________________________ Contact name: _______________________________________________ Phone: ______________________________________________________ ----------------------------------------------------------------- Thank you--we value your input! ----------------------------------------------------------------- This report is authorized by law (15 U.S.C. 1512 et seq., 15 U.S.C. 171 et seq.). While you are not required to respond, your cooperation is needed to make the results of this evaluation comprehensive, accurate, and timely. Public reporting burden for this collection of information is estimated to average ten minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Reports Clearance Officer, International Trade Administration, Rm. 4001, U.S. Dept. of Commerce, Washington, D.C. 20230, and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Paperwork Reduction Project (0625-0217), Washington, D.C. 20503. ----------------------------------------------------------------- FORM ITA 4130P-I (rev. 5/95) OMB. No. 0625-0217; Expires 05/31/2002

Source: U. S. Department of Commerce - National Trade Data Bank, June 22, 2000