Provisional Translation
| OTO No. | 110 | Classification | MHW-78 |
|---|---|---|---|
| Date of Acceptance | April 18, 1983 | Ministry/Agency Receiving Complaint | Ministry of International Trade and Industry |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Domestic firm | Exporting Countries | Germany |
| Subject | Expedition of the examination process and prompt notification in case the application content has any defect in the examination for permission of the import of a medical device (blood pressure manometer). | ||
| Details of Measures | In this case, the applicant had applied a product out of JIS Standards as one under JIS Standards, which was revealed in the examination process. Explanations were made to the complainant that about 8,000 cases of applications for approval of medical devices were submitted annually, and at present it took about 2-3 months from reception of an application by the prefectural office to its examination, and that efforts had been made in the past to speed up the process of approval, but in future further efforts would be made to do so through operation of the approval system according to the kind of medical devices. |
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| Classification of Processing | A | Directions | II-a |
| Remarks | Improvement measures were taken on September 30, 1985. | ||