6th Report of Market Access Ombudsman Council (March 16, 2000)

2-(1) Promoting mutual certification when medical devices are imported

1. Complainant: Tokyo Chamber of Commerce and Industry

2. Ministry concerned: Ministry of Health and Welfare

3. Complaint:

When new medical devices are imported, even though they may be approved for sale and use by the U.S. Food and Drug Administration (FDA) or carry the CE mark, indicating certification in Europe, import approval must be obtained after carrying out various tests and application procedures. It takes between six months and three years to obtain import approval, and this is reflected in the cost of imported medical devices.
Approval procedures in Japan should be radically streamlined, in the case of medical devices approved by the FDA or carrying the CE mark.

4. Corresponding Policy of the Ministries concerned:

The ministry believes that it is not possible to simplify approval procedures for medical devices approved in other countries, so that the quality, efficacy and safety of medical devices used in Japan may be ensured.
However, to reduce the burden on applicants and speed up the supply of medical devices useful for health and medical care, test data carried out in other countries is accepted for the application of approval, in the case the data fit valid guidelines and requirements in Japan. The ministry also actively responds when other countries request meetings to discuss mutual approval for medical devices.

5. Remarks
The complainant accepted this policy.