加拿大外贸
我们是供应商，国内I类医疗器械出口加拿大，客户需要Health Canada Licence，请问这个是什么证书，是不是MDL，MDEL？是不是要找认证机构办理？评论
加拿大卫生部依据CMDCAS进行评估的许可
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加拿大卫生署认定的有资格的认证机构能提供质量体系认证证书。加拿大医疗器械法规规定,Ⅱ类、Ⅲ类、Ⅳ类医疗器械都必须具有质量体系认证证书。n生产者的许可。器械生产商要向加拿大卫生署申请获得许可证或是授权才能销售他们的产品。Ⅰ类医疗器械生产商、Ⅰ类、Ⅱ类、Ⅲ类、Ⅳ类医疗器械进口商和销售商必须获得“许可证”。n产品许可。Ⅱ类、Ⅲ类、Ⅳ类医疗器械生产商要向加拿大卫生署申请获得“器械许可证”。Ⅱ类医疗器械生产者必须提交有资格的认证机构提供的can/csaiso13488-98生产的证书。Ⅲ类、Ⅳ类医疗器械生产者必须提交有资格的认证机构提供的can/csaiso13485-98设计和生产的证书。
你可以找专业机构办理下哈~~~
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加拿大卫生部(Health Canada)注册--医疗器械经营许可证申报清单（针对销售商）:
a) 营业单位的名称/地址；
b) 作为情况联系人的营业单位代表的名称、职位及电话号码；
c) 介绍营业单位为进口商或销售商或二者兼有；
d) 进口或销售的医疗器械制造者的名称地址；
e) 针对每一制造者，列在卫生部所指定的专家库中与进口或销售医疗专家；
f) 针对每一制造者，进口或销售的器械的分类；
g) 营业单位的高级官员所作的声明，声明营业单位建立并保持与分销记录、投诉处理和召回相关的形成文件的程序；
h) 若营业单位进口医疗器械，见其高级官员声明遵守强制采取报告制度；
I) 当营业单位进口或销售II，III，IV类医疗器械，高层官员声明建立文件化程序以控制这些器械处理、贮存、交付、安装、纠正措施和服务；
j) 在加拿大境内实施(g)至(I)款的各个地址。
每年12月31日营业许可证作废，营业单位应提出再次申请。此外，与美国及欧洲法规类似，加拿大医疗器械条例也要求营业单位和制造者执行事故警戒报告制度。
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是不是要健康证书啊。
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If you are planning on selling medical devices in Canada, you will most likely need to register your product by securing a license. There are two types of licenses issued by Health Canada with different requirements.
Health Canada Medical Device Establishment License (MDEL)
If you manufacture Class I medical devices or IVDs and plan to sell directly into Canada without a distributor, you must secure a Medical Device Establishment License (MDEL). If you choose to sell through distributors in Canada, your distributor is required to have an MDEL. Medical device distributors and importers must secure an MDEL regardless of device classifications.
Health Canada Medical Device License (MDL)
The Canadian Medical Device License (MDL) is required for companies selling Class II, III, or IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit for the company/distributor/importer itself.
Canada's Medical Devices License (MDL) is comparable to the US FDA 510(k) process. The process of securing an MDL is usually faster that a 510(k) for Class II devices, about the same for Class III devices, and more complicated for Class IV devices.
Health Canada Medical Device and Quality Management System Requirements
When applying for a Canadian Medical Device License, you will also need to prove that you have a certified ISO 13485 quality management system that also meets the specific requirements of the Canadian Medical Devices Regulations (CMDR). You can read more about ISO 13485 for Canada here.
加拿大电商做区块链为什么都注册新加坡基金会 目前做区块链项目的客户都会通过注册基金会来作为项目的主体，为什么都在新加坡注册基金会，首先性价比高，而且新加坡市场也比较成熟，项目 加拿大电商露天电影首发——葡中双语字幕《中央车站》 http://bbs.shanghai.com/thread-1714999-1-1.html screen.width*0.7) {this.resized=true; this.width=screen.width*0.7; this.alt='Click here to open new window\nCTRL+Mouse wheel to zoo
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