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醫(yī)療器械注冊變更根據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》（國務(wù)院令第650號）的規(guī)定，已注冊的第二類、第三類醫(yī)療器械，醫(yī)療器械注冊證及其附件載明的內(nèi)容發(fā)生變化，申請人應(yīng)當(dāng)向原注冊部門申請注冊變更，并按照相關(guān)要求提交申報資料。 Time:2018-7-4 15:49:27 View:3506
醫(yī)療器械首次注冊流程根據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》（國務(wù)院令第650號）的規(guī)定，對醫(yī)療器械按照風(fēng)險程度實(shí)行分類管理。第Ⅰ類是風(fēng)險程度低，境內(nèi)生產(chǎn)企業(yè)需要在所在地市藥監(jiān)局進(jìn)行備案，境外醫(yī)療器械生產(chǎn)企業(yè)需要委托境內(nèi)代理人在CFDA進(jìn)行備案。第Ⅱ類是具有中度風(fēng)險，境內(nèi)生產(chǎn)企業(yè)需要在所在地?。ㄖ陛犑校┧幈O(jiān)局進(jìn)行注冊，境外醫(yī)療器械生產(chǎn)企業(yè)需要委托境內(nèi)代理人在CFDA進(jìn)行注冊。第Ⅲ類是具有較高風(fēng)險，均需要在CFDA進(jìn)行注冊。 Time:2018-6-29 11:31:24 View:3627

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