Medical Equipment                                              

 

Japan

Overview                                                       

 

(millions of U.S. $)                    2004               2005(estimated)            2006(estimated)

Total Market Size                    19,069            18,270                            18,218

Total Local Production            14,207            13,670                             13,533

Total Exports                            3,983              3,910                               3,910

Total Imports                            8,845              8,510                               8,595

Imports from the U.S.               5,140              4,795                               4,890

(Note: The figures for 2003 and 2004 are the latest official figures; statistics for 2005 and 2006 are unofficial estimates)

 

The Japanese medical equipment and supplies sector ranks second in the world and continues to be an extremely successful market for American firms, representing an important sector where the United States has consistently achieved trade surpluses with Japan.  The value of Japan's medical device sector has been approximately $18 billion for the last few years.  Traditionally, imports account for approximately 40 percent of this figure, with American firms supplying approximately 60 percent of all imported products.  Total U.S. sales in this sector, including local production by American companies, are valued at more than $6 billion annually.

 

A major revision of the Pharmaceutical Affairs Law in 2005 increased the burden on applicants both in financial and practical terms due to its complicated regulations.  In fact, the number of new device applications made to the Pharmaceutical and Medical Device Agency (PMDA) has decreased since 2005 to about 2 applications per quarter whereas the US FDA receives about 10 applications per quarter.  Japanese medical device importers have became extremely conservative when selecting new partners or devices to import.  To cope with the situation and to eliminate the current 2-3 year “device lag,” the Ministry of Health, Labor and Welfare (MHLW) established in October 2006 a study group to consider quicker approvals for the medical devices and in-vitro diagnostics that are generally available in the United States and Europe but not yet in Japan.   

 

On the reimbursement side, the Japanese Government reduced medical service fees by 3.16% in JFY 2006 — the largest cut ever made.  Of the total reduction, 1.36% will come from doctor's fees (which had been previously cut by 1.3% in 2002) and the remaining 1.80% will come from regular drugs (1.60%) and medical devices (0.20%).  Although the cut on the medical device portion was limited to 0.2%, medical device companies are receiving requests for further discounts from end users as doctor’s fee saw a large cut.  It is expected that the Japanese Government will continue focusing on reducing medical device prices in order to counterbalance increasing healthcare expenditures resulting from Japan’s aging society.   Overall, Japan's market for medical devices is expected to exhibit flat to negative growth in 2007.

 

Best Products/Services                                        

 

American firms will continue to see sales prospects in the more technologically sophisticated product categories.  Those products include pacemakers, advanced interventional cardiology products, artificial implants, catheters and stents. Other areas of projected strong demand include software and other products used in medical information systems and health IT.

 

Opportunities                                  

 

Event:               The International Modern Hospital Show 2007 (IMHS2007)

Dates:               July 11-13, 2007

Venue:              Tokyo Big Sight

Web:                www.noma.or.jp/hs/index-e.html

Products:            Healthcare equipment, medical devices and materials, nursing care related devices and health care information systems.

 

Event:               HOSPEX Japan 2007

Dates:               November 14-16, 2007

Venue: Tokyo Big Sight

Web:                www.jma.or.jp/HOSPEX/english/index.html

Products:            Hospital and welfare facilities, medical treatment equipment, medical information systems, and healthcare/welfare support equipment and related devices.

 

Resources                                                

 

CS Japan Contact: Mr. Hiroyuki Hanawa (Tokyo)            Hiroyuki.Hanawa@N0SPAM.mail.doc.gov

 

Ministry of Health, Labor and Welfare (MHLW)                     www.mhlw.go.jp/

Pharmaceutical and Medical Device Agency (PMDA)            www.pmda.go.jp/

Advanced Medical Technology Association (AdvaMed)            www.advamed.org/

The American Chamber of Commerce in Japan (ACCJ),

Medical Devices and Diagnostics Subcommittee               www.accjmedtech.com/

Japan Federation of Medical Device Associations                 www.jfmda.gr.jp/

(JFMDA)