Provisional Translation
| OTO No. | 71 | Classification | MHW-64 |
|---|---|---|---|
| Date of Acceptance | October 5, 1982 | Ministry/Agency Receiving Complaint | Ministry of Foreign Affairs |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | US firm | Exporting Countries | USA |
| Subject | Concerning the import approval procedure for medical equipments, 1. Acceptance of the approval by the US Food and Drug Administration (FDA) that the product is substantially equivalent to products already on the market and that it is eligible for the 90-day prior notice system and acceptance of the US FDA approval for new medical equipment. 2. Acceptance of the test results made by the Underwriters Laboratories and European test organizations for the purpose of verifying compliance with the international standards (IEC Standards) on electric safety and acceptance of those at 100 volts. 3. With respect to performance data, acceptance of results tested at the foreign manufacturer's facilities outside Japan, and approval to use only one piece of equipment for testing instead of two or three. |
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| Details of Measures | Reply was made as follows: 1. The FDA approval can not replace the Minister's approval, but the import approval procedures for the medical equipments which were proved to be identical with those whose import had already been approved are considerably simplified. The necessary period for approval is about 3 months. 2. As for the electric safety, the data of UL, European official or quasi-official test organs are acceptable. The results tested at 120 V cannot be substituted for those data at 100 V from the safety viewpoint. 3. As for the performance data, the test results by any foreign official or quasi-official test organ obtained at the request of the applicant for import permission are acceptable. Concerning the data, the number of the equipments to be used for the test is allowed to be 1 if there is good reason for it. |
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| Classification of Processing | 1. Ca 2. Cc, Ca 3. Ca |
Directions | 1. II-a 2. II-a, II-b 3. II-a |
| Remarks | |||