Provisional Translation
| OTO No. | 90 | Classification | MHW-70 |
|---|---|---|---|
| Date of Acceptance | January 10, 1983 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | US firm | Exporting Countries | USA |
| Subject | Handling of liquid crystal forehead fever thermometer as general consumers but not medical equipment. | ||
| Details of Measures | Reply was made as follows: This product could not be treated like-general merchandise as it was medical equipment under the Pharmaceutical Affairs Law, because it was used to measure body temperature, and to diagnose or to prevent diseases, but the necessary data for application for approval were simplified as similar products had already been approved. A person who wishes to sell these products in Japan should submit a notification to the authority. With respect to medical devices, the approval and licensing systems will be operated in accordance with the category of the product in question. This will include the expansion of the category of articles which do not require approval. |
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| Classification of Processing | Ca | Directions | I-b |
| Remarks | |||