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.

Increasingly, new areas such as remote medical consulting services, as well as management of medical and prescription histories by means of electronic medical charts, have come to play a more prominent role in the sector.

The welfare sector includes activities that focus on the needs of elderly and disabled persons. Nursing care for the elderly, in particular, is a relatively new field, which came about as a result of the April 2000 launch of the national nursing care insurance system. As of December 2004, a total of 3.22 million people used at-home healthcare services, and the number continues to increase each year. The health care industry in Japan is a promising sector that is expected to continue growing with the trend toward longer life expectancies and the shift from multi-generational to nuclear family units.

The Ministry of Health, Labor, and Welfare (MHLW)guidelines published in 1997 contain specific criteria for the use of such data in Japanese marketing applications data. In order to be recognized as usable by MHLW, the foreign data must meet all of the following requirements:

• The clinical trial must meet Japanese regulatory requirements, such as criteria, international standards, and PMDA guidances, or it must be consistent with Japanese medical and clinical conditions.
• The clinical trial must be conducted by qualified investigators at qualified hospitals, such as public or nonprofit hospitals or university facilities.
• The clinical trial must be conducted in compliance with Japanese GCP regulations, or the foreign country’s equivalent GCP regulations, in conformance with the Declaration of Helsinki. Clinical trial processes and methods are included in this requirement.
• All clinical information, including the raw data, case report forms, and statistical analyses, must be available for audit.

The applicant must describe how the clinical trial data meet the above criteria. The description should include the medical conditions for which the clinical trial was conducted and how the clinical trial conditions fit Japanese conditions.

Documentation that adequately demonstrates that the investigators who conducted the clinical trial had the appropriate abilities, skills, and experience required to conduct the trial, including academic backgrounds, qualifications, publications, and professional society memberships, should be included. Also, documentation that demonstrates that the clinical trial was conducted with appropriate processes and methods, such as a clinical trial protocol, must be included. In addition, the applicant must maintain these data for future audit purposes. All submitted documents associated with a foreign clinical trial must be translated into Japanese.

The clinical trial are often the most time-consuming and expensive element of the application.
As a result, it becomes to help global company who want to sell own products in Japan.