已获得MDEL证书的制造商,进口商或分销商查询途径见下链接:https://health-products.canada.ca/mdel-leim/index-eng.jsp 2、MDEL申请时长 整个MDEL申请流程需120天(从Health Canada接收到申请开始计算;这是Health Canada标准绩效时间,发补问题的时间不算在内)。 3、MDEL首次申请流程概述 Step 1:制造商确定I类器械...
As a Class I device, no Medical Device Licence is required for their sale but an MDEL may be. This Guidance states Health Canada will aim to complete the review of an MDEL application within 24 hours (normally it is 120 days) for applicants seeking to manufacture, import or distribute ...
In mid-2017 the FDA announced its digital health innovation action plan2 and began implementing plan commitments by hiring digital health staff, launching its digital health software precertification pilot program3 (Pre-Cert pilot program), and releasing three new guidance documents—two of which dist...
46]. A significant proportion of the adult population in Europe, the US and Canada have vitamin D deficiency [2,92]. Despite the relationship between sunlight exposure and vitamin D levels, vitamin D deficiency is reportedly also prevalent among populations living in sunny climates including the M...
整个MDEL申请流程需120天(从Health Canada接收到申请开始计算;这是Health Canada标准绩效时间,发补问题的时间不算在内)。 3、MDEL首次申请流程概述 Step 1:制造商确定I类器械信息;进口商经销商确定需进口或经销的器械信息; Step 2:填写MDEL申请表格(英文或法语); ...