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...
3、MDNR (Medical Device National Registry) Listing路径 1)在GHAD system Accounts Services上注册账号 2)在系统上提交申请表和申请材料。 系统路径:GHAD system-Products Services-Low Risk Devices 申请表格:Application Form for Medical Devices Listing 3)申请材料:1. Label 标签样稿;2. IFU/eIFU 说明书;3....
1-MDNR (Medical Device National Registry) Listing要求 与欧盟要求的资料相似。并填写MDS – G5 Guidance on Requirements for Medical Device Listing and Marketing Authorization的Annex (7): Medical Device Listing Application Form。 2-MDMA(MedicalDevicesMarketing Authorization)要求 详细见MDS – G5 Guidance ...
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(正确网址应为:https://sfda.gov.sa/en/medical-equipment-list?productName=&class...
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(正确网址应为: https://sfda.gov.sa/en/medical-equipment-list?productName=&cla...
(解答于20210614SDFA咨询会,参与人员 :Pharma Biotech, Abdulielah, Anwar Madkhali, Nasse Alazaiby, Raghad SFDA, Razan Asally, Sammer) 临床试验流程包括: 1.医院伦理上会 2.SFDA备案 3.IVD Import License 4.Clinical Trail 具体可见MDS-G26 Guidance on Requirements for Clinical Investigations (Trials)...
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=&c...
(解答于20210614SDFA咨询会 参与人员 :Pharma Biotech, Abdulielah, Anwar Madkhali, Nasse Alazaiby, Raghad SFDA, Razan Asally, Sammer) 临床试验流程包括: 1. 医院伦理上会; 2. SFDA备案; 3. IVD Import License; 4. Clinical Trail。具体可见MDS-G26 Guidance on Requirements for Clinical Investigatio...
1-MDNR (Medical Device National Registry) Listing要求 与欧盟要求的资料相似。并填写MDS – G5 Guidance on Requirements for Medical Device Listing and Marketing Authorization的Annex (7): Medical Device Listing Application Form。 2-MDMA(MedicalDevicesMarketing Authorization)要求 ...
MDNR (Medical Device National Registry) Listing要求 与欧盟要求的资料相似。并填写MDS – G5 Guidance on Requirements for Medical Device Listing and Marketing Authorization的Annex (7): Medical Device Listing Application Form。 2-MDMA(MedicalDevicesMarketing Authorization)要求 ...