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醫療器械注冊管理辦法(中英文)翻譯.doc 45頁

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學海無涯苦作舟! 醫療器械注冊管理辦法 Medical Devices Registration Administration Method 總則 Chapter 1 General Provisions 第一條 為規范醫療器械的注冊管理,保證醫療器械的安全、有效,根據《醫療器械監督管理條例》,制定本辦法。 Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device. 第二條 在中華人民共和國境內銷售、使用的醫療器械均應當按照本辦法的規定申請注冊,未獲準注冊的醫療器械,不得銷售、使用。 Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use. 第三條 醫療器械注冊,是指依照法定程序,對擬上市銷售、使用的醫療器械的安全性、有效性進行系統評價,以決定是否同意其銷售、使用的過程。 Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use. 第四條 國家對醫療器械實行分類注冊管理。 Article 4 The state shall classify medical devices and administer them based on this classification. 境內第一類醫療器械由設區的市級(食品)藥品監督管理機構審查,批準后發給醫療器械注冊證書。 Domestic Class I medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authority of the government of the municipalities consisting of districts. 境內第二類醫療器械由省、自治區、直轄市(食品)藥品監督管理部門審查,批準后發給醫療器械注冊證書。 Domestic Class II medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government. 境內第三類醫療器械由國家食品藥品監督管理局審查,批準后發給醫療器械注冊證書。 Domestic Class III medical device shall be inspected, approved and granted with registration certificate by State Food Drug Administration. 境外醫療器械由國家食品藥品監督管理局審查,批準后發給醫療器械注冊證書。 Imported medical devices shall be inspected, approved and granted with registration certificate

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