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中華民國輸出入貨品分類表修訂項目表

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(1)中華民國輸出入貨品分類表 修訂項目表. 異動別 刪除. 貨品號列 8421.19.00.00-4. 增列. 8421.19.00.20-0. 增列. 8421.19.00.99-6 輸入規定代號 (空白) 504. 貨 名 Description of Goods 其他離心分離機 Other centrifuges 血液成分分離機 Blood component separator 其他離心分離機 Other centrifuges. 准許(免除簽發許可證)。 Import permitted (free from licensing) 一、進口人用醫療器材應依下列規定辦理:(一)應檢 附衛生福利部核發之醫療器材許可證影本或同意文件, 並應申報填列醫療器材許可證號碼(十四碼)。(二) 如屬危險性醫療儀器,除應檢附衛生福利部核發之醫療 器材許可證影本,及申報填列醫療器材許可證號碼(十 四碼)外,並須檢附衛生福利部核准醫療機構購置之同 意文件。二、非供人用者免依上述規定辦理。. 1. 原 列 輸入規定. 原 列 輸出規定. 改 列 輸入規定. 改 列 輸出規定. S01 504 S01.

(2) 中華民國輸出入貨品分類表 修訂項目表. 異動別. 貨品號列. 輸出規定代號 (空白) S01. 貨 名 Description of Goods 1. Importation of medical devices for human use must be handled according to the following regulations: (1) A photocopy of the medical devices pre-marketing license or an approval document issued by the Ministry of Health and Welfare should be submitted. In addition, the number of the pre-marketing license (consisting of 14 letters and digits) must be declared and listed in the import declaration . (2) If the medical devices being imported are dangerous, then besides the photocopy of the medical device pre-marketing license and the license number declared and listed in the import declaration, an approval of the medical institutions/facilities procurement from the Ministry of Health and Welfare is also required. 2. Importation of medical devices which are not for human use are exempted from the above regulations.. 准許(免除簽發許可證)。 Export permitted (free from licensing) 敏感貨品清單內列管項目出口(或再出口)至北韓及伊 朗者,應向經濟部國際貿易局或經濟部委任或委託之機 關(構)申請戰略性高科技貨品輸出許可證,並憑以報 關出口。. 2. 原 列 輸入規定. 原 列 輸出規定. 改 列 輸入規定. 改 列 輸出規定.

(3) 中華民國輸出入貨品分類表 修訂項目表. 異動別. 貨品號列. 貨 名 Description of Goods Exporters export/re-export goods of the Sensitive Commodity List to North Korea and Iran shall file an application for strategic high-tech commodities export permit to the BOFT or a government authority (agency) appointed by the Ministry of Economic Affairs.. 3. 原 列 輸入規定. 原 列 輸出規定. 改 列 輸入規定. 改 列 輸出規定.

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