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標準和技術要求起草

標準起草

       現有的醫療器械標準體系從標準級別分為:國家標準、行業標準和醫療器械注冊產品標準。

       1、醫療器械注冊產品標準:由制造商制定,應能保證產品安全有效,并在產品申請注冊時,經設區的市級以上藥品監督管理部門依據國家標準和行業標準相關要求復核的產品標準,其法律地位可視同為行業標準。

       2、該產品有國家或行業標準的,企業可直接采用,不需再制定具體的醫療器械注冊產品標準。該產品無國家或行業標準的,企業必須制定醫療器械注冊產品標準,并執行相關國家、行業標準中的通用技術要求。

       3、醫療器械注冊產品標準與企業標準的關系:生產企業應接受工商及環保等部門的監督,同樣在申請產品注冊和生產企業許可證時也要接受藥監部門的監督。產品注冊、生產許可及使用的監督時都要依據醫療器械注冊產品標準,所以企業在申請產品注冊時必須提交按規定制定的醫療器械注冊產品標準。企業應嚴格貫徹執行《醫療器械標準管理辦法》,同時也應遵守《標準化法》和其他法律法規的規定。

久順企管集團擁有專業的技術隊伍,為客戶提供企業產品注冊標準編制服務。

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