方法一：查阅沙特分类规则MDS – G42 Guidance on Medical Devices Classification，依据分类规则判断产品风险等级。该分类规则与欧盟MDR和IVDR的分类规则类似，可查看MDCG指南作为参考。方法二：在SFDA证书查询数据库Medical equipment list (https://sfda.gov.sa/en/medical-equipment-listproductName=&classificationId=&...
1 S.F.D.A. 全称是Saudi Food & Drug Authority. 即沙特的食品药品监管局. 2 Ghad:一个由沙特食品药品监督管理局(SFDA)实施的电子化妆品通告系统,每款化妆品都必须在这里面注册,并取得注册号,用于在Faseh系统申请COC证书. 3 Faseh Services System: 沙特食品药品总局提供的电子系统,使进口商能够提交食品和...
方法二:在SFDA证书查询数据库Medical equipment list (https://sfda.gov.sa/en/medical-equipment-listproductName=&classificationId=&categoryId=&manufacturerName=BGI%20Europe%20A/S&productNumber=&permissionNumber=&type=MDMATFA&pg=1)中,用产品英文名称进行检索,查找类似产品在SFDA的分类。 上述的方法一、二...
名词解释 1 S.F.D.A. 全称是Saudi Food & Drug Authority. 即沙特的食品药品监管局. 2 eCosma:一个由沙特食品药品监督管理局(SFDA)实施的电子化妆品通告系统, 3 SASO-COC:即老的 Certificate of Conformity(清关证书) ECOSMA NOTIFICATION化妆品电子通信系统详解 主要负责有关化妆品制造、进口和销售程序要求的...
电话:+86-571-85691658 传真:+86-571-28867000 邮箱:service@normaltci.com 地址:浙江省杭州市滨江区江陵路88号9幢首页>>新闻活动>>行业动态出口沙特提示沙特标准局SFDA将更新含有麝香和龙涎香的产品相关法规 近日,沙特食品药品管理局SFDA(Saudi Food & Drug Authority)发布了一份最新《含麝香和龙涎香化妆品指南》...
QIMA, a leading provider of quality control and supply chain compliance solutions, announced in April 2022 that it has been approved as a Notified Body by the Saudi Food and Drug Authority (SFDA) to certify cosmetic products being imported or sold in the Kingdom of Saudi Arabia. QIMA is equ...
方法二:在SFDA证书查询数据库Medical equipment list(正确网址应为: https://sfda.gov.sa/en/medical-equipment-list?productName=&classificationId=&categoryId=&manufacturerName=BGI%20Europe%20A/S&productNumber=&permissionNumber=&type=MDMATFA&pg=1 ...
for marketing authorization of health food; review and approve health food; set up classification system for prescription drugs and OTC drugs; establish and improve ADR monitoring system; be responsible for drug reevaluation, review drugs to be withdrawn and formulate national essential medicines list....
AQSIQ is responsible for supervising and managing the record filing of importers and exporters of imported food, establishing the system for the record filing of importers and exporters of imported food, as well as publishing and updating the list on file of importers and exporters of imported ...
” This procedure means that the SFDA does not necessarily review the submitted data, and its system will list the product in its database even if it does not fully meet the applicable cosmetic standards at the time of listing. Consequently, the applicant must ensure the product complies with...