20171214(懶人包)衛生福利部：「醫療器材管理法」草案。

20171214(懶人包)衛生福利部：「醫療器材管理法」草案。

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DownloadNow Download Downloadtoreadoffline Government&Nonprofit Dec.14,2017 817views 行政院會後記者會(第3580次會議) Readmore R.O.C.ExecutiveYuan Follow 20201121臺美經濟繁榮夥伴對話事實清單 R.O.C.ExecutiveYuan 20201119【懶人包】衛生福利部：「因應秋冬COVID-19疫情防治」 R.O.C.ExecutiveYuan 20201119【懶人包】教育部：「私立高級中等以上學校退場條例」草案 R.O.C.ExecutiveYuan 20201119【法條】教育部：「私立高級中等以上學校退場條例」草案 R.O.C.ExecutiveYuan 20201119【懶人包】國家發展委員會：「智慧政府資料治理推動成效」 R.O.C.ExecutiveYuan 【懶人包】20201112經濟部：「振興三倍券新增發放對象」報告 R.O.C.ExecutiveYuan 【懶人包】20201112勞動部：「國際技能競賽推動成效」報告 R.O.C.ExecutiveYuan 【懶人包】20201112教育部：「優化技職校院實作環境計畫辦理情形」報告 R.O.C.ExecutiveYuan 【懶人包】20201112內政部：「消防設備人員法」草案 R.O.C.ExecutiveYuan 【法條】20201112內政部：「消防設備人員法」草案 R.O.C.ExecutiveYuan RelatedBooks Freewitha30daytrialfromScribd Seeall Ricochet:ConfessionsofaGunLobbyist RichardFeldman (5/5) Free TheSecondAmendment:ABiography MichaelWaldman (3.5/5) Free ArmedAmerica:TheRemarkableStoryofHowandWhyGunsBecameasAmericanasApplePie ClaytonE.Cramer (4.5/5) Free Control:ExposingtheTruthAboutGuns GlennBeck (3.5/5) Free ThatUsedtoBeUs:HowAmericaFellBehindintheWorldItInventedandHowWeCanComeBack ThomasL.Friedman (4/5) Free Fear:TrumpintheWhiteHouse BobWoodward (3.5/5) Free FireandFury:InsidetheTrumpWhiteHouse MichaelWolff (3.5/5) Free TheUnitedStatesofTrump:HowthePresidentReallySeesAmerica BillO'Reilly (3/5) Free The9/11Report:TheNationalCommissiononTerroristAttacksUpontheUnitedStates TheNationalCommissiononTerroristAttacksUpontheUnitedStates (4/5) Free WhiteRage:TheUnspokenTruthofOurRacialDivide CarolAnderson (3.5/5) Free LyndonJohnsonandtheAmericanDream DorisKearnsGoodwin (3.5/5) Free AFightingChance ElizabethWarren (3.5/5) Free Siege:TrumpUnderFire MichaelWolff (3.5/5) Free Rage BobWoodward (3.5/5) Free HidinginPlainSight:TheInventionofDonaldTrumpandtheErosionofAmerica SarahKendzior (5/5) Free ThisFightIsOurFight:TheBattletoSaveAmerica'sMiddleClass ElizabethWarren (3.5/5) Free RelatedAudiobooks Freewitha30daytrialfromScribd Seeall PlanofAttack BobWoodward (4/5) Free SecretEmpires:HowtheAmericanPoliticalClassHidesCorruptionandEnrichesFamilyandFriends PeterSchweizer (4/5) Free BushatWar:InsidetheBushWhiteHouse BobWoodward (3.5/5) Free TheLimitsofPower:TheEndofAmericanExceptionalism AndrewJ.Bacevich (4/5) Free TheEducationofanIdealist:AMemoir SamanthaPower (4.5/5) Free SettleforMore MegynKelly (4/5) Free TheCreationoftheAmericanRepublic,1776-1787 GordonS.Wood (4.5/5) Free HegemonyorSurvival:America’sQuestforGlobalDominance NoamChomsky (4.5/5) Free TheFamily:TheSecretFundamentalismattheHeartofAmericanPower JeffSharlet (4/5) Free ClintonCash:TheUntoldStoryofHowandWhyForeignGovernmentsandBusinessesHelpedMakeBillandHillaryRich PeterSchweizer (4/5) Free FireandFury:InsidetheTrumpWhiteHouse MichaelWolff (4/5) Free TheTruth(withjokes) AlFranken (4/5) Free Trumpocracy:TheCorruptionoftheAmericanRepublic DavidFrum (4/5) Free Anti-IntellectualisminAmericanLife RichardHofstadter (4.5/5) Free Fear:TrumpintheWhiteHouse BobWoodward (4.5/5) Free TheRevoltoftheElitesandtheBetrayalofDemocracy ChristopherLasch (4.5/5) Free 1Like Statistics Notes PeiShangWang , -- 3yearsago Views Totalviews 817 OnSlideShare 0 FromEmbeds 0 NumberofEmbeds 0 Actions Shares 0 Downloads 11 Comments 0 Likes 1 Nonotesforslide 20171214(懶人包)衛生福利部：「醫療器材管理法」草案。

1. 1 醫療器材管理法草案說明 2017.12.14 2. 衛生福利部 MinistryofHealthandWelfare MinistryofHealthandWelfare 2 立法目的 健全醫療器材管理制度 建構符合國際潮流之醫療器材法規 配合國內產業發展需求 因應醫療器材科技發展 3. 衛生福利部 MinistryofHealthandWelfare MinistryofHealthandWelfare 3 制定重點 納入從事設計並以其名義上市者為醫療器材製造業者。

鼓勵產業研發及產品創新，納入新創醫療器材加速上市 及配套機制，以嘉惠病患。

促進產業技術研發、產品創新 納入醫療器材維修業者管理。

針對特定醫療器材之販售及供應型態加以管理。

完善醫療器材多元化科技產業管理 賦予醫療器材商及醫事機構建立及保存產品直接供應來 源及流向資料之義務。

推動醫療器材運銷品質管理，確保產品品質不至於運銷 過程中減損。

健全產品流向及運銷品質管理 4. 衛生福利部 MinistryofHealthandWelfare MinistryofHealthandWelfare 4 制定重點 部分低風險之醫療器材改採電子化線上登錄制度，並以 年度申報延續登錄效力。

落實醫療器材風險分級管理 納入醫療器材臨床試驗相關規範。

明定執行經公告無顯著風險之醫療器材臨床試驗，無需 申請主管機關核准。

建構醫療器材臨床試驗管理 部分特定高風險醫療器材須執行安全監視，醫事機構應 予配合。

賦予廠商主動監控上市後產品之風險管理，並進行必要 矯正預防措施。

強化上市後醫療器材安全監督管理 5. Thankyouforyourattention. 5 20201121臺美經濟繁榮夥伴對話事實清單 R.O.C.ExecutiveYuan 20201119【懶人包】衛生福利部：「因應秋冬COVID-19疫情防治」 R.O.C.ExecutiveYuan 20201119【懶人包】教育部：「私立高級中等以上學校退場條例」草案 R.O.C.ExecutiveYuan 20201119【法條】教育部：「私立高級中等以上學校退場條例」草案 R.O.C.ExecutiveYuan 20201119【懶人包】國家發展委員會：「智慧政府資料治理推動成效」 R.O.C.ExecutiveYuan 【懶人包】20201112經濟部：「振興三倍券新增發放對象」報告 R.O.C.ExecutiveYuan 【懶人包】20201112勞動部：「國際技能競賽推動成效」報告 R.O.C.ExecutiveYuan 【懶人包】20201112教育部：「優化技職校院實作環境計畫辦理情形」報告 R.O.C.ExecutiveYuan 【懶人包】20201112內政部：「消防設備人員法」草案 R.O.C.ExecutiveYuan 【法條】20201112內政部：「消防設備人員法」草案 R.O.C.ExecutiveYuan 行政院會後記者會(第3580次會議) Views Totalviews 817 OnSlideshare 0 Fromembeds 0 Numberofembeds 0 Actions Downloads 11 Shares 0 Comments 0 Likes 1 1Like Statistics Notes × ShareClipboard × Facebook Twitter LinkedIn Link Publicclipboardsfeaturingthisslide × Nopublicclipboardsfoundforthisslide Selectanotherclipboard × Lookslikeyou’veclippedthisslidetoalready. Createaclipboard Youjustclippedyourfirstslide! Clippingisahandywaytocollectimportantslidesyouwanttogobacktolater.Nowcustomizethenameofaclipboardtostoreyourclips. Name* Description Visibility OtherscanseemyClipboard Cancel Save SpecialOffertoSlideShareReaders × TheSlideSharefamilyjustgotbigger.Younowhaveunlimited*accesstobooks,audiobooks,magazines,andmorefromScribd. Activateyourfree60daytrial Cancelanytime.