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)
Top of Page
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.
Top of Page
ISA Customer Satisfaction Survey
U.S. Department of Commerce
* International Trade Administration*
The Commercial Service
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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: ______________________________________________________
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Thank you--we value your input!
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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.
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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
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