聚福彩票
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。

聚福彩票

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