口罩防护服加拿大注册

醉雨聽風

请问各位老师，医用口罩（一次性使用医用口罩、医用外科口罩、医用防护口罩），防护口罩（KN95/N95/FFP2），防护服（EN14126）如何进入加拿大市场？我网上看到是说医用口罩在加拿大是I类，拿到MDEL证书即可，但是没找到医用口罩应该符合什么标准，也没找到防护口罩怎么进入加拿大市场。近日收到加拿大官方消息，受疫情影响，可以销往加拿大指定疫情相关的医疗器械，原文如下：
How to import and sell designated medical devices
Medical devices permitted for exceptional importation and manufactured for sale under the Interim Order may be imported into or manufactured for sale in Canada, provided they are on the List. There are two ways to be placed on the List:
•     Health Canada may add a medical device to the List without receiving a proposal.
•     An establishment requests to have a medical device added to the List. If Health Canada adds the requested products to the List, it will inform you of its decision.
To request to be added to the List, an establishment should complete and submit the Health Canada Application Form for Exceptional Importation and Sale which is available on the Health Canada website. The completed application form and French and/or English copies of the labels should be submitted electronically to Health Canada at:hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca
Health Canada will assess the application and may contact the applicant for additional clarification or product specific information. The assessment will consider a number of factors including, but not limited to, product type and availability of supply.
To import a device on the List, importers must notify Health Canada, at leastfive calendar days before the day on which the device is imported, by completing the COVID-19 Medical Device Exceptional Importation and Sale Notification Form which is available on the Health Canada website. Notifications should be sent to:hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca.

但是仍没搞懂，从官网下载的表单上看，都要填医疗器械注册号，但是我们没有在加拿大注册过口罩，其他器械倒是有注册，这种情况下，是按照正常途径进行口罩注册，还是按照疫情期间发的消息按照特殊路径走？两种路径分别怎么走？

AZER

目前应该是要CE和国内410白名单许可，你们有吗？如果有可联系我

wflyxm

学习了

醉雨聽風

AZER 发表于 2020-4-8 17:23
目前应该是要CE和国内410白名单许可，你们有吗？如果有可联系我

CE是有的，国内410白名单是什么意思呢？

AZER

据说是海关认可的名单

醉雨聽風

AZER 发表于 2020-4-9 14:37
据说是海关认可的名单

我对海关的政策法规不了解……

醉雨聽風

最新收到加拿大邮件，按照I类进行注册，资料齐全后24小时即可完成审核，非常方便。

醉雨聽風

最新收到加拿大邮件，按照I类进行注册，资料齐全后24小时即可完成审核，非常方便。