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加拿大MDL认证是什么,和MDEL认证的区别?

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Health Canada Medical Device License (MDL) Approvals and Registration

加拿大医疗器械许可证(MDL)批准和注册

If you sell medical devices in Canada, you will probably need to secure a license. There are two licenses issued by Health Canada (Canada's FDA).

如果您想在加拿大销售医疗器械,您需要获得许可证。加拿大FDA颁布了2种许可证。

 

Health Canada Medical Device Establishment License (MDEL)

加拿大医疗器械企业许可证(MDEL)

Class I medical device and in vitro diagnostic device manufacturers must secure a Medical Device Establishment License (MDEL) if selling directly into Canada and not through a distributor. However, if you sell through distributors in Canada, then your distributor must have an MDEL. Distributors and importers of medical devices and in vitro diagnostic devices, regardless of the device classifications, must secure a MDEL.

NOTE: Manufacturers of Class II, III and IV medical devices and in vitro diagnostic devices do not require an MDEL.

I类医疗器械和体外诊断设备制造商如果不是通过分销商而是直接把设备销售到加拿大必须获得医疗器械企业许可证(MDEL)。但是,如果是通过分销商销售到加拿大,那么你的分销商必须获得MDEL。医疗器械和体外诊断设备分销商和进口商,不管医疗设备的分类,必须获得MDEL。

注意:II类,III类和IV类医疗器械和体外诊断设备制造商不需要获得MDEL。

 

Health Canada Medical Device License (MDL)

加拿大医疗器械许可证(MDL)

The Canadian Medical Device License (MDL) is required for manufacturers of Class II, III, and IV medical devices in Canada. The MDL is a product approval and should not be confused with the MDEL, which is a permit for the company/distributor/importer itself. Canada's Medical Devices License (MDL) is comparable to the US FDA 510(k) process, except the process of securing a MDL is usually faster for Class II devices, about the same for Class III devices and more complicated for Class IV devices.

在加拿大II类,III类和IV类医疗器械制造商需要获得医疗器械许可证(MDL)。MDL是产品许可证不要和MDEL相混淆,MDEL是颁布给企业/经销商/进口商本身。加拿大医疗器械许可证(MDL)可以和美国的FDA 510(K)过程相类似,对于II类医疗器械获得MDL的过程会稍快些,III类也是相同的,对于IV类就更复杂些。

 

When applying for a Canadian Medical Device License, you will also need to prove that you have a certified ISO 13485:2003 quality system that ALSO meets the specific requirements of the Canadian Medical Device Regulations (CMDR).

当申请加拿大医疗器械许可证的时候,你还需要提供经过认证的ISO13485:2003质量系统并且符合加拿大医疗器械法规(CMDR)特定的要求。


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