哪些醫療器械可以不進(jìn)行臨床試驗？

test4

　　眾所周知，辦理醫療器械注冊或者備案事務(wù)的人員需要具有相應的專(zhuān)業(yè)知識，熟悉醫療器械注冊或者備案管理的法律、法規、規章和技術(shù)要求，不然醫療器械產(chǎn)品需要不需要進(jìn)行臨床試驗都不清楚。那么，哪些醫療器械可以不進(jìn)行臨床試驗呢？

　　根據醫療器械監督管理條例的相關(guān)規定，第一類(lèi)醫療器械風(fēng)險程度低，國家實(shí)行產(chǎn)品備案管理，不需要進(jìn)行臨床試驗；由于第二類(lèi)醫療器械具有中度風(fēng)險，第三類(lèi)醫療器械具有較高風(fēng)險，國家對這兩類(lèi)醫療器械實(shí)行產(chǎn)品注冊管理，所以申請這兩類(lèi)醫療器械產(chǎn)品注冊通常需要進(jìn)行臨床試驗。

　　不過(guò)，有些醫療器械也是可以免于進(jìn)行臨床試驗的，具體目錄由國務(wù)院食品藥品監督管理部門(mén)制定、調整并公布。一般來(lái)說(shuō)，滿(mǎn)足下列情形之一的，可以免于進(jìn)行臨床試驗：

　　一、工作機理明確、設計定型，生產(chǎn)工藝成熟，已上市的同品種醫療器械臨床應用多年且無(wú)嚴重不良事件記錄，不改變常規用途的；

　　二、通過(guò)非臨床評價(jià)能夠證明該醫療器械安全、有效的；

　　三、通過(guò)對同品種醫療器械臨床試驗或者臨床使用獲得的數據進(jìn)行分析評價(jià)，能夠證明該醫療器械安全、有效的。

gvgwe

頂．支持，路過(guò)！

oiokd

http://hkjum190057.51sole.com/companynewsdetail_135712285.htm
http://hkjum190057.51sole.com/companynewsdetail_135712255.htm
http://hkjum190057.51sole.com/companynewsdetail_135712228.htm
http://hkjum190057.51sole.com/companynewsdetail_135712209.htm
http://hkjum190057.51sole.com/companynewsdetail_135712175.htm
http://hkjum190057.51sole.com/companynewsdetail_135712157.htm
http://hkjum190057.51sole.com/companynewsdetail_135712122.htm
http://hkjum190057.51sole.com/companynewsdetail_135712092.htm
http://hkjum190057.51sole.com/companynewsdetail_135712065.htm
http://hkjum190057.51sole.com/companynewsdetail_135712041.htm
http://hkjum190057.51sole.com/companynewsdetail_135674823.htm
http://hkjum190057.51sole.com/companynewsdetail_135674808.htm
http://hkjum190057.51sole.com/companynewsdetail_135674791.htm
http://hkjum190057.51sole.com/companynewsdetail_135674774.htm
http://hkjum190057.51sole.com/companynewsdetail_135674751.htm
http://hkjum190057.51sole.com/companynewsdetail_135674732.htm
http://hkjum190057.51sole.com/companynewsdetail_135674712.htm
http://hkjum190057.51sole.com/companynewsdetail_135674691.htm
http://hkjum190057.51sole.com/companynewsdetail_135674658.htm
http://hkjum190057.51sole.com/companynewsdetail_135674566.htm
http://hkjum190057.51sole.com/companyproductdetail_167121188.htm
http://hkjum190057.51sole.com/companyproductdetail_167121102.htm
http://hkjum190057.51sole.com/companyproductdetail_167121015.htm
http://hkjum190057.51sole.com/companyproductdetail_167120899.htm
http://hkjum190057.51sole.com/companyproductdetail_167120814.htm
http://hkjum190057.51sole.com/companyproductdetail_167120257.htm
http://hkjum190057.51sole.com/companyproductdetail_167120164.htm
http://hkjum190057.51sole.com/companyproductdetail_167120092.htm
http://hkjum190057.51sole.com/companyproductdetail_167120013.htm
http://hkjum190057.51sole.com/companyproductdetail_167119922.htm
http://hkjum190057.51sole.com/companyproductdetail_167119821.htm
http://hkjum190057.51sole.com/companyproductdetail_167119743.htm
http://hkjum190057.51sole.com/companyproductdetail_167119654.htm
http://hkjum190057.51sole.com/companyproductdetail_167119578.htm
http://hkjum190057.51sole.com/companyproductdetail_167119478.htm
http://hkjum190057.51sole.com/companyproductdetail_167119390.htm
http://hkjum190057.51sole.com/companyproductdetail_167119308.htm
http://hkjum190057.51sole.com/companyproductdetail_167119227.htm
http://hkjum190057.51sole.com/companyproductdetail_167119105.htm
http://hkjum190057.51sole.com/companyproductdetail_167118709.htm

oiokd

http://www.yixuan123.com/thread-480089-1-1.html
http://www.yixuan123.com/thread-480090-1-1.html
http://www.yixuan123.com/thread-480091-1-1.html
http://www.yixuan123.com/thread-480092-1-1.html
http://www.yixuan123.com/thread-480093-1-1.html
http://www.yixuan123.com/thread-480094-1-1.html
http://www.yixuan123.com/thread-480095-1-1.html
http://www.yixuan123.com/thread-480096-1-1.html
http://www.yixuan123.com/thread-480097-1-1.html
http://www.yixuan123.com/thread-480098-1-1.html
http://www.yixuan123.com/thread-480099-1-1.html
http://www.yixuan123.com/thread-480100-1-1.html
http://www.yixuan123.com/thread-480101-1-1.html
http://www.yixuan123.com/thread-480102-1-1.html
http://www.yixuan123.com/thread-480103-1-1.html
http://www.yixuan123.com/thread-480104-1-1.html
http://www.yixuan123.com/thread-480105-1-1.html
http://www.yixuan123.com/thread-480106-1-1.html
http://www.yixuan123.com/thread-480107-1-1.html
http://www.yixuan123.com/thread-480108-1-1.html
http://www.yixuan123.com/thread-480109-1-1.html
http://www.yixuan123.com/thread-480110-1-1.html
http://www.yixuan123.com/thread-480111-1-1.html
http://www.yixuan123.com/thread-480112-1-1.html
http://www.yixuan123.com/thread-480113-1-1.html
http://www.yixuan123.com/thread-480114-1-1.html
http://www.yixuan123.com/thread-480115-1-1.html
http://www.yixuan123.com/thread-480116-1-1.html
http://www.yixuan123.com/thread-480117-1-1.html
http://www.yixuan123.com/thread-480118-1-1.html
http://www.yixuan123.com/thread-480119-1-1.html
http://www.yixuan123.com/thread-480120-1-1.html
http://www.yixuan123.com/thread-480121-1-1.html
http://www.yixuan123.com/thread-480122-1-1.html
http://www.yixuan123.com/thread-480123-1-1.html
http://www.yixuan123.com/thread-480124-1-1.html
http://www.yixuan123.com/thread-480125-1-1.html
http://www.yixuan123.com/thread-480126-1-1.html
http://www.yixuan123.com/thread-480127-1-1.html
http://www.yixuan123.com/thread-480128-1-1.html
http://www.yixuan123.com/thread-480129-1-1.html
http://www.yixuan123.com/thread-480130-1-1.html
http://www.yixuan123.com/thread-480132-1-1.html
http://www.yixuan123.com/thread-480133-1-1.html
http://www.yixuan123.com/thread-480134-1-1.html
http://www.yixuan123.com/thread-480135-1-1.html
http://www.yixuan123.com/thread-480136-1-1.html
http://www.yixuan123.com/thread-480137-1-1.html
http://www.yixuan123.com/thread-480138-1-1.html
http://www.yixuan123.com/thread-480139-1-1.html
http://www.yixuan123.com/thread-480140-1-1.html
http://www.yixuan123.com/thread-480141-1-1.html
http://www.yixuan123.com/thread-480142-1-1.html
http://www.yixuan123.com/thread-480143-1-1.html
http://www.yixuan123.com/thread-480144-1-1.html
http://www.yixuan123.com/thread-480145-1-1.html
http://www.yixuan123.com/thread-480146-1-1.html
http://www.yixuan123.com/thread-480147-1-1.html
http://www.yixuan123.com/thread-480148-1-1.html
http://www.yixuan123.com/thread-480149-1-1.html
http://www.yixuan123.com/thread-480150-1-1.html
http://www.yixuan123.com/thread-480151-1-1.html
http://www.yixuan123.com/thread-480152-1-1.html
http://www.yixuan123.com/thread-480153-1-1.html
http://www.yixuan123.com/thread-480154-1-1.html
http://www.yixuan123.com/thread-480155-1-1.html
http://www.yixuan123.com/thread-480156-1-1.html
http://www.yixuan123.com/thread-480157-1-1.html
http://www.yixuan123.com/thread-480158-1-1.html
http://www.yixuan123.com/thread-480159-1-1.html
http://www.yixuan123.com/thread-480160-1-1.html
http://www.yixuan123.com/thread-480161-1-1.html
http://www.yixuan123.com/thread-480162-1-1.html
http://www.yixuan123.com/thread-480163-1-1.html
http://www.yixuan123.com/thread-480164-1-1.html
http://www.yixuan123.com/thread-480176-1-1.html
http://www.yixuan123.com/thread-480177-1-1.html
http://www.yixuan123.com/thread-480178-1-1.html
http://www.yixuan123.com/thread-480179-1-1.html
http://www.yixuan123.com/thread-480180-1-1.html
http://www.yixuan123.com/thread-480181-1-1.html
http://www.yixuan123.com/thread-480182-1-1.html
http://www.yixuan123.com/thread-480183-1-1.html
http://www.yixuan123.com/thread-480184-1-1.html
http://www.yixuan123.com/thread-480185-1-1.html
http://www.yixuan123.com/thread-480186-1-1.html
http://www.yixuan123.com/thread-480187-1-1.html
http://www.yixuan123.com/thread-480188-1-1.html
http://www.yixuan123.com/thread-480189-1-1.html
http://www.yixuan123.com/thread-480190-1-1.html
http://www.yixuan123.com/thread-480191-1-1.html
http://www.yixuan123.com/thread-480192-1-1.html
http://www.yixuan123.com/thread-480193-1-1.html
http://www.yixuan123.com/thread-480194-1-1.html
http://www.yixuan123.com/thread-480195-1-1.html
http://www.yixuan123.com/thread-480196-1-1.html
http://www.yixuan123.com/thread-480197-1-1.html
http://www.yixuan123.com/thread-480198-1-1.html
http://www.yixuan123.com/thread-480199-1-1.html
http://www.yixuan123.com/thread-480200-1-1.html
http://www.yixuan123.com/thread-480201-1-1.html
http://www.yixuan123.com/thread-480202-1-1.html
http://www.yixuan123.com/thread-480203-1-1.html
http://www.yixuan123.com/thread-480204-1-1.html
http://www.yixuan123.com/thread-480205-1-1.html
http://www.yixuan123.com/thread-480206-1-1.html
http://www.yixuan123.com/thread-480207-1-1.html
http://www.yixuan123.com/thread-480208-1-1.html
http://www.yixuan123.com/thread-480209-1-1.html
http://www.yixuan123.com/thread-480210-1-1.html
http://www.yixuan123.com/thread-480211-1-1.html
http://www.yixuan123.com/thread-480212-1-1.html
http://www.yixuan123.com/thread-480213-1-1.html
http://www.yixuan123.com/thread-480214-1-1.html
http://www.yixuan123.com/thread-480215-1-1.html
http://www.yixuan123.com/thread-480216-1-1.html
http://www.yixuan123.com/thread-480217-1-1.html
http://www.yixuan123.com/thread-480218-1-1.html
http://www.yixuan123.com/thread-480219-1-1.html
http://www.yixuan123.com/thread-480220-1-1.html
http://www.yixuan123.com/thread-480221-1-1.html
http://www.yixuan123.com/thread-480222-1-1.html
http://www.yixuan123.com/thread-480223-1-1.html
http://www.yixuan123.com/thread-480224-1-1.html
http://www.yixuan123.com/thread-480225-1-1.html
http://www.yixuan123.com/thread-480226-1-1.html
http://www.yixuan123.com/thread-480227-1-1.html
http://www.yixuan123.com/thread-480228-1-1.html
http://www.yixuan123.com/thread-480229-1-1.html
http://www.yixuan123.com/thread-480230-1-1.html
http://www.yixuan123.com/thread-480231-1-1.html
http://www.yixuan123.com/thread-480232-1-1.html
http://www.yixuan123.com/thread-480233-1-1.html
http://www.yixuan123.com/thread-480234-1-1.html
http://www.yixuan123.com/thread-480235-1-1.html
http://www.yixuan123.com/thread-480236-1-1.html
http://www.yixuan123.com/thread-480237-1-1.html
http://www.yixuan123.com/thread-480238-1-1.html
http://www.yixuan123.com/thread-480239-1-1.html
http://www.yixuan123.com/thread-480240-1-1.html
http://www.yixuan123.com/thread-480241-1-1.html
http://www.yixuan123.com/thread-480242-1-1.html
http://www.yixuan123.com/thread-480243-1-1.html
http://www.yixuan123.com/thread-480244-1-1.html
http://www.yixuan123.com/thread-480245-1-1.html
http://www.yixuan123.com/thread-480246-1-1.html
http://www.yixuan123.com/thread-480247-1-1.html
http://www.yixuan123.com/thread-480248-1-1.html
http://www.yixuan123.com/thread-480249-1-1.html
http://www.yixuan123.com/thread-480250-1-1.html
http://www.yixuan123.com/thread-480251-1-1.html
http://www.yixuan123.com/thread-480252-1-1.html
http://www.yixuan123.com/thread-480253-1-1.html
http://www.yixuan123.com/thread-480254-1-1.html
http://www.yixuan123.com/thread-480255-1-1.html
http://www.yixuan123.com/thread-480256-1-1.html
http://www.yixuan123.com/thread-480257-1-1.html
http://www.yixuan123.com/thread-480258-1-1.html
http://www.yixuan123.com/thread-480259-1-1.html
http://www.yixuan123.com/thread-480260-1-1.html
http://www.yixuan123.com/thread-480261-1-1.html
http://www.yixuan123.com/thread-480262-1-1.html
http://www.yixuan123.com/thread-480263-1-1.html
http://www.yixuan123.com/thread-480264-1-1.html
http://www.yixuan123.com/thread-480265-1-1.html
http://www.yixuan123.com/thread-480266-1-1.html
http://www.yixuan123.com/thread-480267-1-1.html
http://www.yixuan123.com/thread-480268-1-1.html
http://www.yixuan123.com/thread-480269-1-1.html
http://www.yixuan123.com/thread-480270-1-1.html
http://www.yixuan123.com/thread-480271-1-1.html
http://www.yixuan123.com/thread-480272-1-1.html
http://www.yixuan123.com/thread-480273-1-1.html
http://www.yixuan123.com/thread-480274-1-1.html
http://www.yixuan123.com/thread-480275-1-1.html

oiokd

http://www.yjsqsn.com/bazisuanming/3386.html
http://www.yjsqsn.com/bazisuanming/3387.html
http://www.zqxszx.com/lianxi/302.html
http://www.zqxszx.com/lianxi/303.html
https://www.03ky.com/bbs-3693-1-1.html

oiokd

http://hkjum190057.51sole.com/companynewsdetail_135455800.htm
http://hkjum190057.51sole.com/companynewsdetail_135455772.htm
http://hkjum190057.51sole.com/companynewsdetail_135455749.htm
http://hkjum190057.51sole.com/companynewsdetail_135455727.htm
http://hkjum190057.51sole.com/companynewsdetail_135455700.htm
http://hkjum190057.51sole.com/companynewsdetail_135455678.htm
http://hkjum190057.51sole.com/companynewsdetail_135455660.htm
http://hkjum190057.51sole.com/companynewsdetail_135455634.htm
http://hkjum190057.51sole.com/companynewsdetail_135455588.htm
http://hkjum190057.51sole.com/companynewsdetail_135455539.htm
http://hkjum190057.51sole.com/companynewsdetail_135410690.htm
http://hkjum190057.51sole.com/companynewsdetail_135410649.htm
http://hkjum190057.51sole.com/companynewsdetail_135410514.htm
http://hkjum190057.51sole.com/companynewsdetail_135410488.htm
http://hkjum190057.51sole.com/companynewsdetail_135410470.htm
http://hkjum190057.51sole.com/companynewsdetail_135410438.htm
http://hkjum190057.51sole.com/companynewsdetail_135410406.htm
http://hkjum190057.51sole.com/companynewsdetail_135410239.htm
http://hkjum190057.51sole.com/companynewsdetail_135410206.htm
http://hkjum190057.51sole.com/companynewsdetail_135410179.htm
http://hkjum190057.51sole.com/companyproductdetail_166469888.htm
http://hkjum190057.51sole.com/companyproductdetail_166469694.htm
http://hkjum190057.51sole.com/companyproductdetail_166469596.htm
http://hkjum190057.51sole.com/companyproductdetail_166469427.htm
http://hkjum190057.51sole.com/companyproductdetail_166469326.htm
http://hkjum190057.51sole.com/companyproductdetail_166469171.htm
http://hkjum190057.51sole.com/companyproductdetail_166469020.htm
http://hkjum190057.51sole.com/companyproductdetail_166468928.htm
http://hkjum190057.51sole.com/companyproductdetail_166468836.htm
http://hkjum190057.51sole.com/companyproductdetail_166468737.htm
http://hkjum190057.51sole.com/companyproductdetail_166468660.htm
http://hkjum190057.51sole.com/companyproductdetail_166468565.htm
http://hkjum190057.51sole.com/companyproductdetail_166468491.htm
http://hkjum190057.51sole.com/companyproductdetail_166468389.htm
http://hkjum190057.51sole.com/companyproductdetail_166468186.htm
http://hkjum190057.51sole.com/companyproductdetail_166468125.htm
http://hkjum190057.51sole.com/companyproductdetail_166468043.htm
http://hkjum190057.51sole.com/companyproductdetail_166467949.htm
http://hkjum190057.51sole.com/companyproductdetail_166467895.htm
http://hkjum190057.51sole.com/companyproductdetail_166467827.htm

o拼多多券商城k

Θ騙販子團隊
騙子QQ723323134,騙子微信kkk111223
845725254
67537346
1336510365
820112280
723323134
505761913
微信 k91551
464250413
766481639
547625716
582668028
770037091

拼多多優(yōu)惠券商城 全場(chǎng)都有券

免拼團 一個(gè)也拼的拼多多

自己搜索好貨

電腦端入口http://www.wz10086.top保存下圖手機版入口二維碼防走丟

www.pinduoduo10086.xyz
www.sihu45.online
www.weixinqun.online
www.youhuiquan.我愛(ài)你

www.youhuiquan.xn--6qq986b3xl

q拼多多券商城j

〓騙販子團隊
騙子QQ723323134,騙子微信kkk111223
845725254
67537346
1336510365
820112280
723323134
505761913
微信 k91551
464250413
766481639
547625716
582668028
770037091

拼多多優(yōu)惠券商城 全場(chǎng)都有券

免拼團 一個(gè)也拼的拼多多

自己搜索好貨

電腦端入口http://www.wz10086.top保存下圖手機版入口二維碼防走丟

www.pinduoduo10086.xyz
www.sihu45.online
www.weixinqun.online
www.youhuiquan.我愛(ài)你

www.youhuiquan.xn--6qq986b3xl

ohnfb

http://www.sun989.com/thread-782301-1-1.html
http://www.sun989.com/thread-782302-1-1.html
http://www.sun989.com/thread-782303-1-1.html
http://www.sun989.com/thread-782304-1-1.html
http://www.sun989.com/thread-782305-1-1.html
http://www.sun989.com/thread-782306-1-1.html
http://www.sun989.com/thread-782307-1-1.html
http://www.sun989.com/thread-782308-1-1.html
http://www.sun989.com/thread-782309-1-1.html
http://www.sun989.com/thread-782310-1-1.html
http://www.sun989.com/thread-782368-1-1.html
http://www.sun989.com/thread-782369-1-1.html
http://www.sun989.com/thread-782370-1-1.html
http://www.sun989.com/thread-782371-1-1.html
http://www.sun989.com/thread-782372-1-1.html
http://www.sun989.com/thread-782373-1-1.html
http://www.sun989.com/thread-782374-1-1.html
http://www.sun989.com/thread-782375-1-1.html
http://www.sun989.com/thread-782376-1-1.html
http://www.sun989.com/thread-782377-1-1.html
http://www.sun989.com/thread-782378-1-1.html
http://www.sun989.com/thread-782379-1-1.html
http://www.sun989.com/thread-782380-1-1.html
http://www.sun989.com/thread-782381-1-1.html
http://www.sun989.com/thread-782382-1-1.html
http://www.sun989.com/thread-782383-1-1.html
http://www.sun989.com/thread-782384-1-1.html
http://www.sun989.com/thread-782385-1-1.html
http://www.sun989.com/thread-782386-1-1.html
http://www.sun989.com/thread-782387-1-1.html
http://www.sun989.com/thread-782388-1-1.html
http://www.sun989.com/thread-782389-1-1.html
http://www.sun989.com/thread-782390-1-1.html
http://www.sun989.com/thread-782397-1-1.html
http://www.sun989.com/thread-782398-1-1.html
http://www.sun989.com/thread-782399-1-1.html
http://www.sun989.com/thread-782400-1-1.html
http://www.sun989.com/thread-782401-1-1.html
http://www.sun989.com/thread-782402-1-1.html
http://www.sun989.com/thread-782403-1-1.html
http://www.sun989.com/thread-782404-1-1.html
http://www.sun989.com/thread-782405-1-1.html
http://www.sun989.com/thread-782406-1-1.html
http://www.sun989.com/thread-782407-1-1.html
http://www.sun989.com/thread-782408-1-1.html
http://www.sun989.com/thread-782409-1-1.html
http://www.sun989.com/thread-782410-1-1.html
http://www.sun989.com/thread-782411-1-1.html
http://www.sun989.com/thread-782412-1-1.html
http://www.sun989.com/thread-782413-1-1.html

香港社區網(wǎng)

鑒定完畢！

澳門(mén)生活網(wǎng)b

此貼有意思~













第五代QQ機器人、QQ群機器人、論壇QQ機器人、智能客服機器人、QQplus機器人、QQ群互聯(lián)機器人..聯(lián)系QQ800829129 QQ群28352615