Provisional Translation
| OTO No. | 346 | Classification | MHW-176 |
|---|---|---|---|
| Date of Acceptance | February 1, 1988 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Japan Trade Association (proxy complaint) | Exporting Countries | USA |
| Subject | Concerning the import of medical equipment, 1. Acceptance of the US clinical trial data and omission of the Japanese clinical trial date for products and systems that have been approved by the US Food and Drug Administration. 2. Exemption from attaching approval by the Ministry of Health and Welfare for domestic medical equipment returned for repair. |
||
| Details of Measures | 1. It was replied that, in principle, Japan already accepts foreign-generated clinical trial data for medical devices, but that Japanese-generated clinical trial data is required as supplementary data in date in the case of medical devices that are to be implanted in the patient's body and that could give influence on the compatibility of the living body. 2. It was replied that copies of the notification of manufacturing medical devices for export or the application for manufacturing approval (license) of medical device manufactured in accordance with the provisions of the Pharmaceutical Affairs Law is reimported to Japan by reason of repairs or any other reason in order to prove that it is the same product as was exported and that it was duly manufactured in Japan. |
||
| Classification of Processing | 1. Cc 2. D |
Directions | 1. II-b 2. II-a |
| Remarks | |||