注冊人制度下產品注冊申報
依據《醫療器械監督管理條例》及《醫療器械生產監督管理辦法》規定，醫療器械注冊人、備案人可以自行生產醫療器械，也可以委托具備相應生產能力的企業生產醫療器械，醫療器械注冊人、備案人承擔醫療器械質量主體責任并按要求申辦醫療器械注冊證或備案憑證，受托生產企業提交注冊人或備案人的醫療器械注冊證或備案憑證申辦醫療器械生產許可證或生產備案憑證。其中具有高風險的植入性醫療器械不得委托生產。
注冊人制度下醫療器械注冊或備案流程
我們的服務
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受托生產及研發技術服務
醫療器械檢測技術服務
注冊人制度下體系規范與輔導
醫療器械注冊申報與跟進
醫療器械生產許可或變更申請
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掃描下方的二維碼訂閱“CIRS醫械合規動態”！實時傳遞最新醫療器械監管法規動態，分享醫療器械注冊成功經驗及經典案例跟蹤醫療器械最新產品安全與法規監管動態，獲得最新一手資訊。
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