醫療器械主文檔登記
依據“醫療器械主文檔登記事項公告”及相關法規規定，涉及醫療器械原材料的成分、工藝等技術保密信息，可以由其醫療器械原材料供貨商進行主文檔登記，當醫療器械注冊申請人在產品注冊申報中需要使用主文檔資料時，主文檔所有者向醫療器械注冊申請人出具授權書，醫療器械注冊申請人將該授權書作為申報資料的一部分代替已登記的主文檔資料提交注冊申請，醫療器械技術審評機構不會向醫療器械注冊申請人披露主文檔資料內容。
醫療器械主文檔是一種技術資料形式，此資料主要包括醫療器械原材料的技術資料：原材料組成成分描述、理化性能研究資料、生物學評價資料、毒理學風險分析資料等
醫療器械主文檔登記流程
我們的服務
境外主文檔中國授權代理人
醫療器械主文檔數據缺口分析
醫療器械主文檔數據解決方案
醫療器械原材料檢測技術服務
醫療器械主文檔登記
醫療器械主文檔更新
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。
① 凡本網注明"稿件來源：“杭州瑞旭科技集團有限公司"的所有文字、圖片和音視頻稿件，版權均屬杭州瑞旭科技集團有限公司所有，任何媒體、網站或個人未經本網協議授權不得轉載、鏈接、轉貼或以其他方式復制發表。已經本網協議授權的媒體、網站，在下載使用時必須注明"稿件來源：杭州瑞旭科技集團有限公司"，違者本網將依法追究責任。
② 本網未注明"稿件來源：杭州瑞旭科技集團有限公司 "的文/圖等稿件均為轉載稿，本網轉載出于傳遞更多信息之目的，并不意味著贊同其觀點或證實其內容的真實性。如其他媒體、網站或個人從本網下載使用，必須保留本網注明的"稿件來源"，并自負版權等法律責任。如擅自篡改為"稿件來源：杭州瑞旭科技集團有限公司"，本網將依法追究責任。如對稿件內容有疑議，請及時與我們聯系。
③ 如本網轉載稿涉及版權等問題，請作者在兩周內速來電或來函與杭州瑞旭科技集團有限公司聯系。
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