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OTO No. |
606 |
Classification |
MHW-251 |
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Date of Acceptance |
June 2, 2000 |
Respective Office Receiving Complaint |
Cabinet Office (Economic Planning Agency) |
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Responsible Ministries |
Ministry of Health, Labour and Welfare (Ministry of Health and Welfare) |
Related Laws |
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Complainant |
Foreign firm |
Exporting Countries |
USA |
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Subject |
Approval of color contact lenses |
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Description of Complaint |
Those willing to import and sell contact lenses that are not sold in Japan must file applications for approval on such imports and sales with the ministry and obtain approval. The complainant filed an application for approval on import and sale of color contact lenses that have been in distribution in Europe and the United States. The ministry has instructed the complainant to remove the improvement of the sight for the eye without any abnormal iris from the purposes of the lenses. The major purpose of contact lenses is to improve the eyesight and color contact lenses are widely used in foreign countries for improving the eyesight. In Japan as well, color contact lenses for improving the eyesight have already been approved. The ministryfs limitation of purposes for the color contact lenses in question can be interpreted as an effective barrier to import and sale of products that are already in distribution in foreign countries. Accordingly, the ministry should not limit the purposes for the color contact lenses in question and promptly give the results of examinations of the color contact lenses in question as medical instruments. |
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Details of Measures |
The ministry replied as follows: (2) The ministry assesses the quality, effectiveness and safety of contact lenses based on the documentation attached to the applications while listening to experts and considering how the lenses are used overseas. Whether to limit the purposes of lenses subject to the applications should be decided on a case-by-case basis from the viewpoint of the effectiveness and safety, based on the documentation. Before deciding to limit the purposes for certain contact lenses, however, the ministry gives opportunities for applicants to present opinions. (3) The complainant and its affiliate Japanese firm have applied for approval on the contact lenses that the complainant manufactures. The ministry has understood that the contact lenses have been developed and colored for patients whose eyes have some external appearance problems including a loss of the iris (the black iris for Japanese). Since the use of such contact lenses only for the improvement of the eyesight could be riskier than the use of conventional contact lenses, careful considerations must be given before approval and the ministry is examining appropriate purposes of the contact lenses in question based on the documentation as submitted by the applicant. (4) After assessing the contact lenses in question based on the documentation as submitted, the ministry has decided that the contact lenses in question may be approved as the contact lenses not only for solving external appearance problems for eyes but also for improving the sight of normal eyes as long as they are sold in an appropriate manner. Approval may be given shortly. |
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Status of Processing |
Processed (July 5, 2000) |
Classification of Action |
A |
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Remarks |
A written reply was made on July 3, 2000. An additional written reply was made on July 5, 2000. |
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