加拿大醫療器械監管

加拿大醫療器械監管 概述

總要求

所有進入加拿大市場銷售的醫療器械,無論是加拿大本地生產還是進口,均需獲得加拿大醫療器械主管部門,加拿大衛生部(Health Canada)的許可。

醫療器械許可證發布后,每年11月1日應由制造者向加拿大衛生部提出再確認申請。

取消生產許可證應在停止加拿大銷售的30日之內提出。 

(注冊+第三方審查)制度

加拿大實行醫療器械產品注冊制度,結合第三方的質量體系審查。

第三方機構指經加拿大醫療器械認證認可機構CMDCAS, Canadian Medical Devices Conformity)認可的機構,簡稱CMDCAS認可機構。

分類

依據風險大小,分為I, II,III,IV四個分類,I類為最低風險,IV類器械風險為最高。 

I類醫療器械豁免注冊;II、III、IV類器械要求注冊。

風險越高的器械,對制造商的注冊要求也越復雜。

盛大乐彩 www.444537.com|WWW.21518.COM|WWW.826085.COM|www.9356x.com|WWW.29018.COM|www.51515i.com|WWW.122286.COM|www.357803.com|WWW.342055.COM|www.638806.com|WWW.334157.COM|www.878466.com|www.cf9906.com|WWW.655748.COM|www.011ac.com|WWW.664340.COM|www.6832m.com|WWW.97058.COM|www.62500.cc|WWW.794337.COM|www.33997q.com|WWW.469700.COM|www.78949y.com|WWW.635852.COM|www.99677r.com|WWW.890991.COM|www.049988.com|WWW.30070.COM|www.032288.com|WWW.524278.COM|www.217880.com|WWW.404318.COM|www.339281.com|WWW.191884.COM|www.317097.com|WWW.450569.COM|www.278207.com|WWW.747402.COM|www.316083.com|WWW.690236.COM|www.234259.com|WWW.905181.COM|www.090392.com|WWW.437004.COM|www.50051hh.com|WWW.47690.COM|www.60108f.com|WWW.18058.COM|www.26163h.com|WWW.475980.COM|www.9999y.cc|WWW.133590.COM|www.622by.com|WWW.778991.COM|www.hm3999.com|WWW.810299.COM|www.hm2777.com|WWW.528161.COM|WWW.511381.COM|www.777768a.com|WWW.75527.COM|www.915990.com|WWW.548155.COM|www.686783.com|WWW.260172.COM|www.593411.com|WWW.328780.COM|www.374277.com|WWW.57838.COM|www.101372.com|www.593500.com|WWW.150270.COM|www.775020.com|WWW.206402.COM|www.738742.com|WWW.584261.COM|www.55fzc.com|WWW.24043.COM|www.29277hh.com|WWW.680694.COM|www.96386j.com|WWW.707747.COM|www.33112a.com|WWW.645939.COM|www.77114m.com|WWW.7376.COM|www.66069.cc|WWW.522012.COM|www.ac3177.com|WWW.261027.COM|WWW.174108.COM|www.915366.com|WWW.239947.COM|www.507670.com|WWW.198994.COM|www.196037.com|WWW.383444.COM|www.80767g.com|WWW.740043.COM|www.33598b.com|WWW.900527.COM|www.w408.com|www.983888.com|WWW.13801.COM|www.599416.com|WWW.812707.COM|www.463552.com|WWW.286433.COM|www.097968.com|WWW.855506.COM|www.50788f.com|WWW.589253.COM|www.2109j.com|WWW.168232.COM|WWW.751590.COM|www.757209.com|WWW.645234.COM|www.208990.com|WWW.681182.COM|www.50080y.com|WWW.622008.COM|www.071wy.com|WWW.553025.COM|WWW.382654.COM|www.769971.com|WWW.663520.COM|www.507433.com|WWW.160270.COM|www.99788s.com|WWW.827357.COM|www.7793x.com|WWW.594483.COM|WWW.555446.COM|www.605733.com|WWW.250455.COM|www.54400v.com|WWW.719234.COM|www.1035q.com|WWW.362061.COM|WWW.548991.COM|www.599290.com|WWW.29466.COM|www.43131b.com|WWW.879869.COM|www.686pp.com|WWW.567147.COM|WWW.670821.COM|www.558402.com|WWW.20662.COM|www.196807.com|WWW.877388.COM|www.07163h.com|WWW.358004.COM|WWW.690993.COM|www.558424.com|WWW.283810.COM|www.95777w.com|WWW.273509.COM|www.33tdc.com|www.927233.com|WWW.887676.COM|www.296676.com|WWW.676641.COM|www.71399f.com|WWW.82602.COM|www.53wcp.com|www.909888.com|WWW.444636.COM|www.192880.com|WWW.809733.COM|www.60123m.com|WWW.70882.COM|www.c142.vip|www.767387.com|WWW.202367.COM|www.66376i.com|WWW.469766.COM|www.1368u.cc|WWW.666764.COM|WWW.770179.COM|www.191060.com|WWW.632832.COM|www.26163j.com|WWW.32351.COM|WWW.607585.COM|www.460689.com|WWW.747187.COM|www.55228c.com|WWW.45893.COM|WWW.185145.COM|www.506257.com|WWW.730045.COM|www.78949f.com|WWW.35278.COM|WWW.323412.COM|www.550435.com|WWW.454577.COM|www.65707z.com|WWW.393883.COM|WWW.6132.COM|www.504533.com|WWW.50824.COM|www.08588x.com|WWW.79518.COM|WWW.678974.COM|www.517411.com|WWW.428881.COM|www.81678g.com|WWW.446220.COM|WWW.214150.COM|www.575872.com|WWW.592471.COM|www.29277l.com|WWW.26525.COM|WWW.272961.COM|www.401271.com|WWW.79015.COM|www.3933m.cc|www.922109.com|WWW.439654.COM|www.50064a.com|WWW.5335.COM|WWW.794563.COM|www.436106.com|WWW.160277.COM|www.8839f.com|www.976281.com|WWW.123589.COM|www.0377555.com|WWW.313770.COM|www.qucw1.com|www.701361.com|WWW.256901.COM|www.61233d.com|WWW.508585.COM|WWW.522312.COM|www.160882.com|WWW.666386.COM|www.tctx2.com|www.669268.com|WWW.901601.COM|www.26299h.com|WWW.741125.COM|WWW.143594.COM|www.055972.com|WWW.432599.COM|WWW.167291.COM|www.452166.com|WWW.1827.COM|www.3126u.com|www.810625.com|WWW.443224.COM|www.88266x.com|WWW.870133.COM|WWW.370356.COM|www.335214.com|WWW.457811.COM|www.hy5355.com|www.652561.com|WWW.91954.COM|www.5091j.com|www.843879.com|WWW.32376.COM|www.81233m.com|WWW.20052.COM|WWW.192001.COM|www.199602.com|WWW.531833.COM|WWW.626883.COM|www.335484.com|WWW.37018.COM|www.ch8234.com|www.456586.com|WWW.197872.COM|www.085wy.com|www.657269.com|WWW.75742.COM|www.3126f.com|www.890723.com|WWW.303861.COM|www.33997h.com|WWW.763369.COM|WWW.654769.COM|www.99677b.com|WWW.176543.COM|WWW.94977.COM|www.040435.com|WWW.743755.COM|WWW.326276.COM|www.275780.com|WWW.590380.COM|WWW.658089.COM|www.375939.com|WWW.200492.COM|www.sygj7.com|www.550116.com|WWW.817452.COM|www.1999ac.com|www.644680.com|WWW.345943.COM|www.1222ac.com|www.657666.com|WWW.645788.COM|www.371o.cc|www.675266.com|WWW.122286.COM|www.7782w.com|www.808523.com|WWW.237988.COM|www.15899.cc|www.931499.com|WWW.162310.COM|www.33588x.com|www.979500.com|WWW.333357.COM|www.67767.cc|www.818646.com|WWW.487004.COM|www.8499t.com|www.902775.com|WWW.830044.COM|www.87668.cc|www.867865.com|WWW.659566.COM|www.5441r.com|www.701496.com|WWW.318212.COM|www.33ckb.com|www.549677.com|WWW.356669.COM|www.c129.vip|www.309388.com|WWW.456153.COM|WWW.521402.COM|www.095335.com|WWW.204599.COM|WWW.756448.COM|www.43818k.com|www.912451.com|WWW.420850.COM|www.72gcw.com|www.388634.com|WWW.561177.COM|WWW.514955.COM|www.91233p.com|WWW.522012.COM|WWW.140572.COM|www.022s.cc|www.338995.com|WWW.112249.COM|WWW.536972.COM|www.35918r.com|www.755216.com|WWW.718816.COM|WWW.736132.COM|www.111307.com|WWW.594633.COM|WWW.802348.COM|www.1368y.cc|www.397836.com|