產品詳情
1.進口復出口的:
(1)提交由藥品監督管理部門批準出具的進口醫療注冊證明。
(2)提交出口醫療物資聲明【附件1】。
(1) Submit the import medical registration certificate approved and issued by the drug regulatory department.
(2) Submit the declaration of exported medical materials [Annex 1].
2.未獲得國內醫療器械產品注冊證書,但獲得國外標準認證或注冊的醫療物資:
(1)提交出口醫療物資聲明(中英文)【附件2】;
(2)生產企業需在商務部提供的取得國外標準認證或注冊的生產企業清單中。(中國醫藥保健品進出口商會網站動態更新)
(1) Submit the statement of export medical materials (in Chinese and English) [Annex 2];
(2) Production enterprises shall be listed in the list of production enterprises with foreign standard certification or registration provided by the Ministry of Commerce. (website update of China Chamber of Commerce for import and export of medical and health products)

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