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經濟部國際貿易局 貨品輸入規定變更明細表

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經濟部國際貿易局 貨品輸入規定變更明細表

輸入規定代號說明

(空白) 准許(免除簽發許可證)。

Import permitted (free from licensing)

504 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. 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.

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經濟部國際貿易局 貨品輸入規定變更明細表

輸入規定代號說明

602 (一)進口屬電信管制射頻器材應經許可之項目,由海關驗憑國家通

訊傳播委員會核發之電信管制射頻器材進口許可證後放行。但屬軍事 專用者,由海關驗憑國防部核發之電信管制射頻器材進口許可證後放 行。(二)如非屬應經許可之電信管制射頻器材,不論民用或軍事專 用,均可免憑前述許可證放行。(三)經國家通訊傳播委員會或其認 可委託之驗證機構型式認證合格或符合性聲明證明之無線電信終端設 備或低功率射頻電機,免請領進口許可證。但應憑國家通訊傳播委員 會或其認可委託之驗證機構核發之電信終端設備審定證明、電信終端 設備符合性聲明證明、低功率射頻電機型式認證證明或低功率射頻電 機符合性聲明證明辦理通關。(備註:原由電信總局核發之前揭證明 文件亦適用本規定。)

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經濟部國際貿易局 貨品輸入規定變更明細表

輸入規定代號說明

(1) The import of controlled telecommunications radio frequency devices shall be released by the customs against the import permit issued by the National Communications Commission (NCC), but those imports for military use shall be released by the customs against the import permit issued by the Ministry of National Defense. (2) The import of non-controlled telecommunications radio frequency devices may be released by the customs without the above import permit, whether for military use or not. (3) The Telecommunications Terminal Equipment (TTE) and Low-power Radio-frequency Devices (LP) which have been granted approval certificate or Declaration of Conformity (DoC) certificate by the NCC or the Regulatory Certification Bodies (RCBs) may exempt from application of import permit. But those imports shall be released by the customs against TTE approval certificate, TTE DoC certificate, LP approval certificate or LP DoC certificate issued by the NCC or the RCBs.

(Note: The import permit issued by the Directorate of General Telecommunications (DGT) is also valid under this regulation.)

C02 本項下部分商品屬於經濟部標準檢驗局公告應施進口檢驗商品。

Some of the commodities under this item subject to legal import inspection announced by the Bureau of Standards, Metrology and Inspection, ministry of economic affairs.

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經濟部國際貿易局 貨品輸入規定變更明細表

輸入規定代號說明

MP1 (一)大陸物品有條件准許輸入,應符合「大陸物品有條件准許輸入

項目、輸入管理法規彙總表」之規定。(二)「大陸物品有條件准許 輸入項目、輸入管理法規彙總表」內列有特別規定「MXX」代號者

,應向國際貿易局辦理輸入許可證;未列有特別規定「MXX」代號 者,依一般簽證規定辦理。

(1) Importation of Mainland China products in this category is conditionally permitted. The importation should conform to the regulations of "Consolidated List of Conditional Import Items of Mainland China Origin and Regulations Governing Import of Mainland China Origin Commodities".(2) Importation of items on the "Consolidated List of Conditional Import Items of Mainland China Origin and Regulations Governing Import of Mainland China Origin Commodities" with "MXX" code requires Import Permit issued by the BOFT;

Importation of items without "MXX" code shall be subject to the general code of import permit issuance.

MW0 大陸物品不准輸入。

Importation of Mainland China products is prohibited.

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Importation of drugs (including pharmaceutical products, active pharmaceutical ingredients, diagnostics and biological products) for human use requires either of the following: (1)

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The importation should conform to the regulations of "Consolidated List of Conditional Import Items of Mainland China Origin and Regulations Governing Import of Mainland

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For importing dry goods:(1) A photocopy of business license for dealing with Chinese medicine ( or pharmaceutical manufacturing license issued by the Ministry of Health and Welfare