第II/III類醫療器械注冊
依據《醫療器械監督管理條例》規定，第II、III類醫療器械施行注冊管理，在投放中國市場前，應先向藥品監督管理部門提交注冊申請并獲得醫療器械注冊證。同時確保在醫療器械生產質量管理規范體系下開展研發及生產經營活動。
醫療器械注冊主要參考法規
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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