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醫(yī)療器械行業(yè)開始洗牌，行業(yè)政策匹配和市場痛點需如何應對？

2000年頒布的第一部條例鑒定了醫(yī)療器械行業(yè)有法可依的基礎; 2014年第一次修訂 ,讓醫(yī)療器械監(jiān)管有了質(zhì)的飛躍; 2017年的5月和10月又做了兩次修訂。

第三次修訂的幾個要點:
新增第九條:醫(yī)療器械注冊人或者備案人以自己名義將產(chǎn)品推向市場,應當具備相應的質(zhì)量管理、風險防控、持續(xù)研究、責任賠償?shù)饶芰?確保提交的研究資料和臨床試驗數(shù)據(jù)真實、完整、可追溯，對醫(yī)療器械全生命周期承擔法律責任。

新增第十條:醫(yī)療器械注冊人或者備案人在境外的,應當由其在我國境內(nèi)設立的代表機構(gòu)或者指定我國境內(nèi)具備相應質(zhì)量管理、風險防控、責任賠償能力的企業(yè)法人作為代理人。

新增第十一條:醫(yī)療器械注冊人或者備案人可以自行生產(chǎn)或者銷售醫(yī)療器械,也可以委托符合本條例規(guī)定、具備相應條件的醫(yī)療器械生產(chǎn)經(jīng)營企業(yè)生產(chǎn)或者銷售醫(yī)療器械。醫(yī)療器械注冊人委托他人生產(chǎn)或者銷售的,應當與受托醫(yī)療器械生產(chǎn)經(jīng)營企業(yè)簽訂合同,明確雙方權(quán)利、義務和責任,保證受托企業(yè)的生產(chǎn)經(jīng)營行為符合本條例規(guī)定的要求。

2015醫(yī)療器械政策與市場營銷特訓班

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2023-06-26

2015醫(yī)療器械政策與市場營銷特訓班

2023-06-26

醫(yī)療器械最新法規(guī)文件匯總

2023-06-26

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2022-07-28

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