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APPENDICES
  • Japan’s Regulations for Medical Equipment
  • Product Approval Process for Direct Applications by Foreign Manufacturers
  • Nationwide Medical Insurance Reimbursement System
  • License and Product Approval Requirements
  • International Competitiveness of Japanese Medical Equipment
  • Product Approval and Manufacturer/Importer Licensing Process
  • Distribution Practices in the Japanese Medical Industry
  • Case Study: The Implantable Cardioverter Defibrillator (ICD)
  • Examples of Cost Efficient Technologies as Cited in the Bain Study
  • Ministry of Health and Welfare—Organization Chart
  • Ministry of International Trade and Industry—Organization Chart
  • Diet Members of the Advisory Council on Social Security
  • Members of the Committee on Health and Welfare of the House of the Councilors
  • Japanese Legislative Procedure

 

(Source: "Guide to Medical Device Registration in Japan," MHW, 1997)

Appendix 2. Approval Process for Direct Applications by Foreign Manufacturers

 

Appendix 3. National Medical Insurance Reimbursement System

 

Appendix 4. License and Product Approval Requirements

 

Appendix 5. International Competitiveness of Japanese Medical Equipment

Japan’s medical equipment industry is not internationally competitiveness, despite the country’s high technological manufacturing achievements. Indeed, as shown in Table 2, Japan is much more dependent on imports of medical equipment than it is on imports of other hi-tech equipment.

Table 2. Imports, domestic production, and import penetration, 1989

 

Sector and product category

Imports

(billion yen)

Domestic production

(billion yen)

Import penetration*

(%)

Medial instruments

158

724

17.9

Radio and television sets

44

1,022

4.1

Electronic computing equipment

574

6,384

8.2

Communication equipment

80

2,723

2.9

Semiconductor devices

358

3,515

9.3

Chemical machinery

59

1,142

4.9

*Import penetration = import volume/(domestic production + import volume). No account is taken

of exports, which are small for most of these products.

(Source: "Measuring the Cost of Protection in Japan," Institute for International Economics, 1995)

Imports accounted for 25.7 percent of domestic demand for medical equipment in 1991. In 1993 that share rose to 30.6 percent, and in 1998, imports accounted for over 40 percent of domestic demand.

Appendix 6. Product Approval and Manufacturer/Importer Licensing Processes

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