医疗器械在泰国的TFDA注册流程: ① 申请者准备注册所需的相关文件,并且保证自由销售证明(Certificate of Free Sale)和体系证明合规; ② 申请者将注册所需的文件提交至TFDA服务中心; ③ 提交的文件由医疗设备控制部门的监管人员进行审核和记录; ④ 工作人员将申请人的档案记录到数据库系统中,随后向申请人提供一个参...
IVD印度注册需要准备资料有:印度使馆认证Form9(源于法规有模板),贸促会认证资料:自由销售证书FSC,质量管理体系类文件ISO13485,ISO9001,CE认证类文件EC certificate和 自我声明,标签说明书和分析报告COA。 IVD叙利亚注册需要准备资料有:SDS(SAFETY DATA SHEET),叙利亚使馆认证资料:自由销售证书FSC,质量管理体系类文件ISO134...
医疗器械在泰国的TFDA注册流程: ① 申请者准备注册所需的相关文件,并且保证自由销售证明(Certificate of Free Sale)和体系证明合规; ② 申请者将注册所需的文件提交至TFDA服务中心; ③ 提交的文件由医疗设备控制部门的监管人员进行审核和记录; ④ 工作人员将申请人的档案记录到数据库系统中,随后向申请人提供一个参...
TFDA禁止进口二手/翻新的设备,进口产品在原产国必须取得自由销售证明(Certificateof Free Sale)。 一、泰国进口医疗器械及分类TFDA对医疗器械的分类区别于绝大多数国家,分类如下:需获得许可的医疗器械,等级高(Licensed MedicalDevice,Class I );需获得通知的医疗器械,等级次之( NotificationMedical Device, ClassII);...
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Factory Price Disposable Medical Anesthesia Breathing Circuit Kit with ISO Certificate US$4.00-5.00 / Set Medical Disposable Anesthesia Circuit Kit US$2.50-5.00 / Set Medical Air Management Disposable Anesthesia Circuit Kit US$2.50-6.50 / Set Silicone Ventilation Anesthe...
Certificate of Free Sale or Good Manufacturing Practice Certificate Names, functions, and percentage of each ingredient in the product formulation Clear and complete loose labels or artworks of all packaging size and commercial product packaging
◇Certificates of Free Sale/FSC (domestic or overseas) ◇Transaction of foreign CE Certificate Notarization ◇Transaction of foreign FSC Certificate Notarization ◇Certificate Training for Medical Device ◇Appearance Design for Medical Device ◇Clinical Application Consultation for Medical Device ...
Certificate CE, FDA, ISO13485, ISO9001 Package PP Bag in Box Then Packed in Carton OEM&ODM Available Delivery Time 7-20 Days Brand Kangda Product Name Enhanced Sport Waist Protector Sleeve Support (II Size S M L XL XXL Xxxl Transport Package PP Bag in Box Into Carton Spe...
registration, requesting an official FDAImports.com registration certificate, and more. While facility registration is an important part of manufacturing and distributing food products, there are other regulatory requirements for companies to follow as well. Visit ourfood and beverage pagefor more ...