Health Canada Medical Device License (MDL) Approvals and Registration

加拿大醫(yī)療器械許可證（MDL）批準(zhǔn)和注冊

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).

如果您想在加拿大銷售醫(yī)療器械，您需要獲得許可證。加拿大FDA頒布了2種許可證。

 

Health Canada Medical Device Establishment License (MDEL)

加拿大醫(yī)療器械企業(yè)許可證（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類醫(yī)療器械和體外診斷設(shè)備制造商如果不是通過分銷商而是直接把設(shè)備銷售到加拿大必須獲得醫(yī)療器械企業(yè)許可證（MDEL）。但是，如果是通過分銷商銷售到加拿大，那么你的分銷商必須獲得MDEL。醫(yī)療器械和體外診斷設(shè)備分銷商和進(jìn)口商，不管醫(yī)療設(shè)備的分類，必須獲得MDEL。

注意：II類，III類和IV類醫(yī)療器械和體外診斷設(shè)備制造商不需要獲得MDEL。

 

Health Canada Medical Device License (MDL)

加拿大醫(yī)療器械許可證（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類，III類和IV類醫(yī)療器械制造商需要獲得醫(yī)療器械許可證（MDL）。MDL是產(chǎn)品許可證不要和MDEL相混淆，MDEL是頒布給企業(yè)/經(jīng)銷商/進(jìn)口商本身。加拿大醫(yī)療器械許可證（MDL）可以和美國的FDA 510(K)過程相類似，對于II類醫(yī)療器械獲得MDL的過程會稍快些，III類也是相同的，對于IV類就更復(fù)雜些。

 

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).

當(dāng)申請加拿大醫(yī)療器械許可證的時候，你還需要提供經(jīng)過認(rèn)證的ISO13485:2003質(zhì)量系統(tǒng)并且符合加拿大醫(yī)療器械法規(guī)（CMDR）特定的要求。

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