Provisional Translation
| OTO No. | 474 | Classification | MHW-218 |
|---|---|---|---|
| Date of Acceptance | May 8, 1992 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Domestic firm | Exporting Countries | USA |
| Subject | Import approval of closed-circulation anesthesia apparatus | ||
| Details of Measures | Under the Pharmaceutical Affairs Law, medical equipment is examined for effectiveness and safety. In the case of the apparatus in this complaint, examination was unable to determine effectiveness and safety in relation to the concentration of the anesthetic used, and the examination for approval of import has taken some time. The complainant was advised that new approval standards for anesthetic evaporator were set out in an administrative memorandum dated July 21, 1992, and that import approval was granted in August 1992. |
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| Classification of Processing | A | Directions | I-a |
| Remarks | Improvement measures were taken on July 21, 1992. | ||